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| 510(k) | | | DeNovo | | | Registration & Listing | | | Adverse Events | | | Recalls | | | PMA | | | HDE | | | Classification | | | Standards |
| CFR Title 21 | | | Radiation-Emitting Products | | | X-Ray Assembler | | | Medsun Reports | | | CLIA | | | TPLC |
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- Edwards Vigilance 8 0 - IB-ED701-A.0 #701 0844 up to 1 from this group up to 1 from this group Edwards Vigilance II 8 0 - IB-ED702-A.0 #702 0844 Edwards Vigileo 8 0 - IB-ED703-A.0 #703 0844 IntelliVue TcG10 2 0 - IB-ED301-A.0 #301 1020 up to 1 up to 1 External device connected using VueLink up to 6c up to 2c - n/a up to 2 up to 4.
- Edwards Vigilance 8 0 - IB-ED701-A.0 #701 0844 Edwards Vigilance II 8 0 - IB-ED702-A.0 #702 0844 Edwards Vigileo 8 0 - IB-ED703-A.0 #703 0844 Gambro Prismaflex 8 0 - IB-ED803-A.0 #803 1020 IntelliVue TcG10 2 0 - IB-ED301-A.0 #301 1020 up to 1 up to 1 External device connected using VueLink up to 6c up to 2c - n/a up to 2 up to 4.
- IFUs and Operator Manuals are subject to change; the most current version is available on this site. If you do not find the document you need, have difficulty accessing the document, or would like to request a printed copy (at no charge), please contact Edwards Support at 1-888-570-4016 or at techsupport@edwards.com.
05 ED Vigilance II QuickR2. Edwards Vigilance II Monitor Quick Reference. See Vigilance II Monitor Operator’s Manual for Detailed Instructions. Oximetry Setup & Calibration. Continuous Cardiac Output. In Vitro Calibration. Continuous Cardiac Output. Connect the Optical Module to the SvO2/ScvO2 color-coded.
| EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER AMC THROMBOSHIELD SWAN-GANZ CATHETER | Back to Search Results |
| | Model Number 777HF8J | | Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535) | | Patient Problem No Consequences Or Impact To Patient (2199) | | Event Date 02/28/2012 | | Event Type Malfunction | | Event Description | It was reported that 'unstable cco value was observed during use. It is unknown what the readings were or if there were any error messages observed. There was no damage noted on the catheter. ' the sample of tracing was not available. There were no patient complications reported. | | Manufacturer Narrative | One catheter was returned with monoject 1. 5cc limited volume syringe for evaluation. No introducer or contamination shield was returned. The thermistor read 37. 0 c when submerged into a 37. 0 c water bath. The catheter was connected to the vigilance i monitor and vigilance ii monitor and 'check thermal filament position' error message was shown on both monitors. According to the operator's manual for the vigilance ii monitor, possible causes for the 'check thermal filament position' message are the following: 'flow around thermal filament may be reduced. Thermal filament may be against vessel wall. Catheter not in patient. ' these error messages can be expected during testing in a static water bath. Thermistor and thermal filament circuit were continuous; there were no open or intermittent conditions. No visible inconsistencies were observed on eeprom data. Both thermistor and thermal filament connectors were opened and found no visible inconsistencies. Resistance value of the thermal filament circuit was measured at 37. 66 ohms, which is within specifications. All through lumens were patent without leakage or occlusion. The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage. No visible damage to the catheter body or returned syringe was observed. The lot number was not provided; therefore, a review of the manufacturing records could not be completed. Visual examinations were performed under 10x magnification. This type of report has been confirmed as related to the manufacturing process. An investigation is underway to determine what actions are needed to prevent recurrence of this type of complaint. | | Manufacturer Narrative | At the initial investigation of the complaint, this was considered an isolated event. A deeper investigation identified a larger issue and corrective actions were implemented. In addition, an awareness training was given to the manufacturing personnel. | | Search Alerts/Recalls |
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| New Search | Submit an Adverse Event Report |
| Type of Device | SWAN-GANZ CATHETER |
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| Manufacturer (Section D) | | EDWARDS LIFESCIENCES, PR | | state rd indus pk 402 km 1.4 | | anasco PR 00610 |
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| Manufacturer (Section G) | | EDWARDS LIFESCIENCES, PR | | state rd indus pk 402 km 1.4 | | anasco PR 92614 |
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| Manufacturer Contact | | frances preston | | one edwards way | | irvine, CA 92614 | | 9492505190 |
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| MDR Report Key | 2508170 |
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| MDR Text Key | 2577768 |
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| Report Number | 2015691-2012-17178 |
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| Device Sequence Number | 1 |
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| Product Code | DQE |
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| Combination Product (Y/N) | N |
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| Reporter Country Code | JA |
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| PMA/PMN Number | K040287 |
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| Number of Events Reported | 1 |
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| Summary Report (Y/N) | N |
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| Report Source | Manufacturer |
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| Source Type | Foreign,Health Professional,User facility,Company Representative |
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| Reporter Occupation |
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| Type of Report | Initial,Followup |
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| Report Date | 02/28/2012 |
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| 1 Device Was Involved in the Event |
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| 0 PatientS WERE Involved in the Event: |
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| Date FDA Received | 03/28/2012 |
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| Is This An Adverse Event Report? | No |
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| Is This A Product Problem Report? | Yes |
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| Device Operator | HEALTH PROFESSIONAL |
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| Device MODEL Number | 777HF8J |
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| Was Device Available For Evaluation? | Yes |
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| Is The Reporter A Health Professional? | No |
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| Was the Report Sent to FDA? | No |
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| Distributor Facility Aware Date | 02/28/2012 |
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| Event Location | Hospital |
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| Date Manufacturer Received | 02/28/2012 |
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| Was Device Evaluated By Manufacturer? | Device Not Returned To Manufacturer |
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| Is The Device Single Use? | Yes |
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| Is this a Reprocessed and Reused Single-Use Device? | No |
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| Type of Device Usage | Initial |
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Edwards Lifesciences - Vigilance II
by Edwards Lifesciences
DESCRIPTION
The Vigilance II monitor gives you the ability to present complex hemodynamic data in a simplified way.The Edwards Lifesciences Vigilance II monitor, when used with a Swan-Ganz advanced technology pulmonary artery catheter or an Edwards oximetry catheter, provides a continuous and comprehensive view of hemodynamic performance - offering you a solution for your critical and most complex patients.
The Vigilance II monitor gives you the ability to present complex hemodynamic data in a simplified way to paint a clearer picture of the patient’s hemodynamic status.
FORUMSView All (6)
Ask a New Question
3Replies-Biomed-sam
3 years ago | 3 years ago Pm procedure
What is the pm procedure for a baxter vigilance II monitorReply |
-Daboy75
5 years ago | 5 years agoEdwards Vigileo Cardiac Monitor does not continue to power up.
It powers up for a while then the monitor turns black and without any beep or sound. Can anyone please give me an idea if any of you guys have encountered this problem before. Thank you. Reply |
0Replies-radtech89
6 years ago | 6 years agoAGFA 75.0 ERRIR 24A8E
ANYONE KNOW WHAT THIS ERROR IS? Reply |
DOCUMENTS / MANUALSView All
FEATURES
- Continuous CO, SvO2, EDV, SVR, and other measured and derived parameters are presented on customized displays selected by the clinician
- Onscreen, customized trend, data relationship, and stat displays provide a complete picture of blood flow and tissue oxygenation for precision patient management
- Interface with the bedside monitor for convenience and display of additional measured and derived parameters such as continuous SVR, DO2, DO2I, VO2, VO2I, O2EI, O2ER, and VQI
- The Vigilance II monitor is the ideal clinical tool for teaching the principles of advanced hemodynamic monitoring to the clinical staff
SPECIFICATIONS
| Height | 9.5 in |
| Length | 8.17 in |
| Weight | 3.43 kg |
| Width | 11.5 in |
Edwards Vigilance Ii Service Manual Download
Additional Specifications
Edwards Vigilance Ii Service Manual 2019
TFT Display: 8.3 in x 6.2 in Active Area
Trend Display: 30 minutes to 24 hours for Trend Graph; 4 Large Parameter Frames
Edwards Vigilance Ii Service Manual Pdf
NEWSView All
Product Showroom: Critical Care Monitors
Edwards Vigilance Ii Service Manual 2020
This month, Medical Dealer explores current trends in critical care monitors.