BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME II HANDPIECE

    MDR report key: 2934846 · Received January 23, 2013

    Report

    Report Number
    1526350-2013-00032
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 26, 2012
    Manufacturer
    ZIMMER MEDICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVAL. THE DEVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON (B)(6) 2012 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. INSPECTION OF THE DEVICE DID NOT OBSERVE ANY DAMAGE. THE LEVER ASSEMBLY FUNCTIONED PROPERLY AND DEVICE MET FUNCTIONAL SPECIFICATIONS. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED, AS NO FAILURES WERE OBSERVED WITH THE DEVICE. AS A PRECAUTION, STANDARD REPAIR PARTS WERE REPLACED. THE DEVICE WAS RECALIBRATED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER DERMATOME II WAS NOT FUNCTIONING. IT WAS REPORTED THAT THE EVENT OCCURRED AT TIME DEVICE WAS RECEIVED AT FACILITY AND WAS NOT IN PT USE. THERE WAS NO REPORT OF PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33194 ZIMMER AIR DERMATOME II HANDPIECE ZIMMER AIR DERMATOME II HANDPIECE GFD ZIMMER MEDICAL NA 500139

    Patients

    Seq Age Sex Outcome Treatment
    1