BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN

    MDR report key: 4774550 · Received May 13, 2015

    Report

    Report Number
    1526350-2015-00091
    Event Type
    Malfunction
    Date Received
    May 13, 2015
    Date of Event
    April 16, 2015
    Report Date
    April 17, 2015
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PRODUCT RETURN SO PHYSICAL INSPECTION AND TESTING OF THE DEVICE WAS NOT COMPLETED. THE REVIEW OF THE DEVICE HISTORY RECORD NOTED NO RELEVANT NON-CONFORMANCES, REQUESTS FOR DEVIATION, OR OTHER ISSUES. THE REVIEW OF THE MFG AND TESTING PROCESSES DISCOVERED NO SYSTEMIC ISSUES WITH THIS DEVICE. WITH THE AVAILABLE INFO THE CUSTOMERS REPORTED EVENT CANNOT BE CONFIRMED. THE PRODUCT IFU WARNS THAT THE BATTERIES SHOULD BE REMOVED FROM THE BATTERY PACK AND THAT THE BATTERY CABLE SHOULD NOT BE CUT. THE MOST PROBABLE CAUSE FOR THIS INCIDENT IS IMPROPER DISPOSAL OF THE DEVICE IN CONTRADICTION OF THE IFU WARNINGS BY THE CUSTOMER. WHEN THE CUSTOMER "PULLED THE POWER CORD OUT OF THE BATTERY PACK" MOST LIKELY THE WIRE STRETCHED UNTIL THE WIRES SNAPPED APART. THIS COULD HAVE THE SAME RESULTS AS CAUSING A SHORT WHEN CUTTING THE WIRES. ONLY AFTER THE BATTERY PACK GETTING HOT WAS THE BATTERY PACK OPENED. THE DEVICE INSTRUCTIONS FOR USE AND THE LABELING ON THE TYVEK LID WARN THAT CUTTING THE BATTERY PACK CABLE COULD LEAD TO SHOCK, EXCESSIVE HEAT AND/OR SPARKS, AND COULD RESULT IN FIRE OR PERSONAL INJURY. THE BATTERIES SHOULD BE PHYSICALLY REMOVED FROM THE BATTERY PACK, CARE SHOULD BE TAKEN AND PERSONAL SAFETY EQUIPMENT SHOULD BE WORN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER PULSAVAC PLUS WAS USED ON A TOTAL KNEE CASE AND IT PERFORMED NORMALLY WITHOUT ANY ISSUE. AFTER THE TOTAL KNEE SURGICAL CASE, THE POWER CORD WAS PULLED FROM THE BATTERY PACK WHILE TEARING DOWN THE DRAPES/STERILE FIELD. AFTERWARD, IT WAS DISCOVERED THAT THE BATTERY PACK WAS HOT. WHEN OPENED, TWO OF THE AA BATTERIES WERE MELTED TOGETHER. THERE WAS NO PT OR USER HARM ASSOCIATED WITH THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311563 PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FQH ZIMMER SURGICAL NA 62971154

    Patients

    Seq Age Sex Outcome Treatment
    1