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Adverse Event Report

BAXTER HEALTHCARE CORP. EDWARDS CRITICAL CARE SWAN GANZ CATHETER   back to search results
Model Number 93A-754H-7.5F
Patient Outcome  Other;
Event Description

The pt had a swan ganz catheter that had been functioning appropriately, when the nurse attempted to wedge the swan, a wedge wave form was not obtained & was not able to aspirate the injected air. Swan ganz was removed & the balloon was found to be broken. No injury was caused to the pt.

 
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Brand NameSWAN GANZ
Type of DeviceCATHETER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
BAXTER HEALTHCARE CORP. EDWARDS CRITICAL CARE
17221 redhill ave.
irvine CA 92714 5627
Device Event Key142267
MDR Report Key145956
Event Key137017
Report NumberMW1012866
Device Sequence Number1
Product CodeDYG
Report Source Voluntary
Report Date 01/19/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/27/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number93A-754H-7.5F
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on February 28, 2009

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