BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN

    MDR report key: 3874628 · Received April 24, 2014

    Report

    Report Number
    1526350-2014-00316
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    December 4, 2013
    Report Date
    April 16, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED FOR PART NUMBER 00515047500, LOT 61792131. THIS LOT WAS MANUFACTURED AND RELEASED INTO INVENTORY ON (B)(4) 2011. THERE WERE NO NON CONFORMANCES DURING MANUFACTURER THAT WOULD BE RELATED TO THIS COMPLAINT. ALL TESTING REQUIREMENTS WERE MET. EVALUATION OF THE DEVICE OBSERVED IT DID NOT FUNCTION WHEN ENGAGING THE SWITCH. INSPECTION OF THE BATTERY PACK DISPLAYED CORROSION ON THE BATTERIES AND THE BATTERY PACK TERMINALS. CONTINUITY OF THE GUN AND SWITCH WAS NORMAL. THE BATTERY PACK WAS NOT AT FULL CHARGE, INDIVIDUAL BATTERY CHARGES VARIED. VARIOUS STAGES OF CORROSION WERE WITNESSED ON THE BATTERY PACK TERMINAL AND THE BATTERY ENDS. SEVERAL BATTERIES DISPLAYED LEAKAGE. THE DEVICE ALSO FAILED TO OPERATE WITH ALL FRESH BATTERIES AND THE BATTERY PACK STILL DISPLAYED LOW VOLTAGE WHEN TESTED DUE TO THE CORROSION ON THE BATTERY PACK TERMINAL. THE CUSTOMER'S REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY CAUSE FOR THIS EVENT IS THE CORROSION OF THE BATTERY PACK TERMINAL DUE TO THE DEGRADATION OF THE BATTERIES. THE CAUSE FOR THE BATTERY DEGRADATION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SWITCH WAS TURNED ON, THE PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN SPRAY KIT DID NOT FUNCTION. THE SWITCH WAS TURNED ON AND OFF SEVERAL TIMES, BUT STILL IT DID NOT OPERATE. 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
    248377 PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN GFD ZIMMER SURGICAL NA 61792131

    Patients

    Seq Age Sex Outcome Treatment
    1