BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM HIP

    MDR report key: 2860145 · Received November 21, 2012

    Report

    Report Number
    1526350-2012-00298
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVAL. A REVIEW OF THE MFG RECORDS INDICATED THAT THERE WERE NO NON-CONFORMANCE DURING MANUFACTURE THAT WOULD BE RELATED TO THIS COMPLAINT. ALL TESTING REQUIREMENTS WERE MET. THE INSPECTION FOUND THAT THE PACKAGING WAS FULL OF CONTAMINATION FROM BATTERIES LEAKING. THE BATTERIES HAD VENTED AND ANODE EJECTION WAS PRESENT. THE WHITE WIRE WAS FOUND DAMAGED INSIDE THE BATTERY PACK. THE INSULATION HAD BEEN REMOVED EXPOSING THE COPPER WIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSAVAC PLUS HAD SEVERE DAMAGE TO THE INSIDE OF THE UNOPENED PACKAGE. ADD'L CLINICAL F/U WITH THE CUSTOMER INDICATED THAT IT APPEARED AS IF THE BATTERY EXPLODED AND DISINTEGRATED WITH THE UNOPENED PACKAGE. THE CUSTOMER ALSO STATED ADDITIONALLY THAT, "THE PIN HAD BEEN LEFT IN." ALTERNATE STOCK PRODUCT WAS IMMEDIATELY AVAILABLE FOR USE AND NO OTHER PRODUCT HAD BEEN IDENTIFIED AS AFFECTED SIMILARLY. THERE WAS NO REPORT OF HARM, INJURY, OR MEDICAL/SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM HIP PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FQH ZIMMER SURGICAL NA 62136498

    Patients

    Seq Age Sex Outcome Treatment
    1