BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN

    MDR report key: 3831844 · Received March 6, 2014

    Report

    Report Number
    1526350-2014-00157
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    December 4, 2013
    Report Date
    February 6, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND THERE WERE NO NON-CONFORMANCES DURING MANUFACTURE THAT WOULD BE RELATED TO THIS COMPLAINT. ALL TESTING REQUIREMENTS WERE MET. THE TRIGGER WAS FOUND IN THE LOW MODE POSITION AS RECEIVED. THE COMPLAINT WAS CONFIRMED. THE UNIT WOULD NOT FUNCTION ON HIGH OR LOW MODE. THE BATTERY CASE WAS OPENED AND FOUND TO HAVE 1 BATTERY (POSITION 3) THAT HAD VENTED ON THE NEGATIVE TERMINAL CAUSING CORROSION. BOTH THE BATTERY AND BATTERY PACK TERMINAL SHOWED CORROSION ON THE NEGATIVE END. THE WIRING WAS ANALYZED AND NO ISSUES WERE IDENTIFIED. ALL BATTERY VOLTAGES WERE TESTED AND WERE ALL FOUND TO BE EXHAUSTED. NEW BATTERY WERE PLACED IN THE BATTERY PACK AND THE UNIT WAS TESTED. IT FUNCTIONED NORMALLY IN HIGH AND OW MODES. THE CAUSE OF THE REPORTED ISSUE IS UNDETERMINED. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRIGGER ON THE PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN SPRAY KIT WOULD NOT SWITCH ON FOR A HIGHER SPEED. THERE WAS NO PATIENT HARM OR DELAY REPORTED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134994 PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1