BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER PULSAVAC PLUS SHOWER SPRAY KIT

    MDR report key: 2020623 · Received February 10, 2011

    Report

    Report Number
    1526350-2011-00024
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    December 20, 2010
    Report Date
    January 12, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR AT THE TIME OF THIS REPORT. A F/U MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER PULSAVAC PLUS BATTERY PACK HAD EXCESSIVE HEAT AND SPARKED AT THE SURGERY. NO HARM/INJURY OF THE PT OR THE SURGEON/NURSES AT THE SURGERY WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER PULSAVAC PLUS SHOWER SPRAY KIT PULSAVAC KIT FQH ZIMMER SURGICAL NA 61352979

    Patients

    Seq Age Sex Outcome Treatment
    1