BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 2103665 · Received May 20, 2011

    Report

    Report Number
    1526350-2011-00103
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR. THE SERVICE RECORDS INDICATE THAT THE DEVICE IS 2 YRS OLD AND THIS IS THE FIRST TIME IN FOR REPAIR SINCE PURCHASED. THE INSPECTION FOUND THAT THE DEVICE WAS OUT OF CALIBRATION. THE CAUSE OF THE REPORTED COMPLAINT IS LIKELY THE DEVICE OUT OF CALIBRATION. THIS IS DUE TO A LACK OF PREVENTATIVE MAINTENANCE. THIS IS A RE-USABLE DEVICE, SUBJECT TO NORMAL WEAR AND TEAR. THE ZIMMER AIR DERMATOME SHOULD BE RETURNED EVERY 12 MONTHS AND THE HOSE EVERY 6 MONTHS FOR INSPECTION AND PREVENTIVE MAINTENANCE. ANNUAL FACTORY CALIBRATION CHECKS ARE STRONGLY RECOMMENDED TO VERIFY CONTINUED ACCURACY. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME WAS SKIPPING. AN ADD'L HARVEST WAS REQUIRED BUT NO ADD'L INTERVENTION WAS NEEDED. ANOTHER UNIT WAS AVAILABLE TO COMPLETE ADD'L GRAFT HARVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1