BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN

    MDR report key: 2211663 · Received August 5, 2011

    Report

    Report Number
    1526350-2011-00167
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER PULSAVAC PLUS "BATTERIES WERE SMOKING AND HOT AFTER USE" AND THAT ONE OF THE BATTERIES LEAKED. CLINICAL FOLLOW-UP REVEALED THROUGH THE REGISTERED NURSE AND TEAM MANAGER THAT THEY SMELLED SOMETHING LIKE "HOT ELECTRIC" WHILE THEY WERE DRAPING FOR THE PROCEDURE. THE PROCEDURE WAS CONTINUED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FQH ZIMMER SURGICAL NA 61780686

    Patients

    Seq Age Sex Outcome Treatment
    1