BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER PULSAVAC PLUS HIP KIT

    MDR report key: 3061360 · Received April 10, 2013

    Report

    Report Number
    1526350-2013-00172
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 23, 2013
    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 RETURNED TO THE MANUFACTURER FOR EVALUATION. NO LOT NUMBER WAS PROVIDED, PRECLUDING REVIEW OF DEVICE HISTORY RECORDS. THE PACKAGING WAS OPENED AND THE CONTENTS EXAMINED. ONE OF THE BATTERIES SHOWED CORROSION ON THE NEGATIVE AND POSITIVE ENDS. THERE WAS ALSO EVIDENCE OF CORROSION ON THE BATTERY TERMINAL. THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THIS COMPLAINT IS A CORRODED BATTERY. THE ROOT CAUSE OF THE CORRODED BATTERY IS NOT KNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALTHOUGH THE ZIMMER PULSAVAC PLUS HIP KIT HAD BEEN SWITCHED ON, THE DEVICE HAD NOT OPERATED. THE RESULT WAS THE SAME EVEN IF THE DEVICE WAS SWITCHED TO "HIGH" AND "LOW" ALTERNATELY MANY TIMES. THERE WAS NO HARM OR DELAY REPORTED, AND PROCEDURE COMPLETED WITH AN ALTERNATE DEVICE. THE RETURNED DEVICE EVALUATION OBSERVED CORROSION ON THE NEGATIVE AND POSITIVE ENDS OF ONE BATTERY. THERE WAS ALSO EVIDENCE OF CORROSION ON THE BATTERY TERMINAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152892 ZIMMER PULSAVAC PLUS HIP KIT ZIMMER PULSAVAC PLUS HIP KIT FQH ZIMMER SURGICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1