BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3871216 · Received April 16, 2014

    Report

    Report Number
    1526350-2014-00285
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 26, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 11/06/2003 AND WAS PREVIOUSLY REPAIRED AT MEDICREA ON 12/09/2013 FOR MAINTENANCE. EVALUATION OF THE DEVICE CONFIRMED THE DEVICE TO BE OUTSIDE CALIBRATION SPECIFICATIONS. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE STANDARD REPAIR PARTS AND PROPER CALIBRATION OF THE DEVICE. IMPROPER HANDLING MOST LIKELY CAUSED THE IMPROPER CALIBRATION OF THE DEVICE. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AIR DERMATOME HANDPIECE HAD CALIBRATION FAILURE. THERE WAS PT INVOLVEMENT AND MORE SKIN HAS BEEN CUT OFF THAN USUAL AND NO ALTERNATE DEVICE WAS RETRIEVED FRO THE USE AND THE SURGERY WENT ON WITH A DELAY OF AROUND 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233407 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1