BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 2102947 · Received May 12, 2011

    Report

    Report Number
    1526350-2011-00095
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 7 YEARS OLD THE LAST REPAIR WAS ON 07/15/2009, FOR A NON RELATED ISSUE. THE INSPECTION FOUND THAT THE DEVICE RAN BELOW SPECIFICATION AND THE THICKNESS LEVEL SETTINGS WERE OUT OF SPECIFICATION AT 0 AND 30 POSITIONS. THE LIKELY CAUSE OF THE REPORTED COMPLAINT WAS AN ERRATIC MOTOR AND THE DEVICE OUT OF CALIBRATION. THESE ARE 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 UNIT WAS CUTTING DIAMOND SHAPES, AS STATED BY THE SURGEON. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THE INCIDENT.

    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