BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME

    MDR report key: 7995080 · Received October 23, 2018

    Report

    Report Number
    0001526350-2018-00956
    Event Type
    Malfunction
    Date Received
    October 23, 2018
    Date of Event
    October 4, 2018
    Report Date
    December 19, 2018
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION. THE DEVICE HISTORY RECORD FOR ZIMMER AIR DERMATOME SERIAL NUMBER (B)(4) WAS REVIEWED NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH MANUFACTURING. THE RECORD REVIEW FOUND ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. THE REPORTED EVENT WAS CONFIRMED BY THE SERVICE TECHNICIAN WHO EVALUATED THE DEVICE. ON 16 OCTOBER 2018, IT WAS REPORTED FROM UNIVERSITY HLT SHREVEPORT THAT THE HOSE WAS LEAKING ON THE END THAT ATTACHES TO A DERMATOME. THE CUSTOMER RETURNED A ZIMMER AIR DERMATOME, SERIAL NUMBER (B)(4), 4 WIDTH PLATES, A SCREWDRIVER, AND A HOSE FOR EVALUATION. EVALUATION OF THE DEVICE ON (B)(6) 2018 NOTED THAT THE CALIBRATION WAS OUT OF SPECIFICATIONS AT THE 0 SETTING BUT WITHIN AT ALL OTHER SETTINGS AND THAT THE MOTOR WAS RUNNING WITHIN MOTOR SPEED SPECIFICATIONS. THE HOSE WAS FOUND TO BE LEAKING AND THE WIDTH PLATES AND SCREWDRIVER WERE BOTH DAMAGED. THE CASE WAS MISSING ITS LATCHES. REPAIR OF THE DEVICE OCCURRED THE SAME DAY AND INVOLVED REPLACING THE VESPEL AND SEMI-CIRCLE BEARINGS, THE DAMAGED WIDTH PLATES, SCREWDRIVER, CASE, AND LEAKING HOSE. THE TECHNICIAN THEN TESTED AND VERIFIED THAT THE DERMATOME WAS FUNCTIONING AS INTENDED. HE THEN RETURNED THE DEVICE TO SERVICE WITHOUT FURTHER INCIDENT. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED. REFERENCE NUMBER (B)(4) ON (B)(6) 2018. WHILE THE SERVICE TECHNICIAN CONFIRMED THE REPORTED EVENT, IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED AS TO WHAT CAUSED THE LEAK ON THE HOSE TO OCCUR. THEREFORE, BASED ON THE INFORMATION PROVIDED, A SPECIFIC ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION AND INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HOSE WAS LEAKING. EVENT OCCURRED DURING TESTING, NO HARM, NO DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838178 ZIMMER AIR DERMATOME DERMATOME GFD ZIMMER SURGICAL, INC. 62441602

    Patients

    Seq Age Sex Outcome Treatment
    1