BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME KIT

    MDR report key: 2102972 · Received May 12, 2011

    Report

    Report Number
    1526350-2011-00096
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR. THE SERVICE RECORDS INDICATE THAT THE DEVICE HAS NOT BEEN IN FOR SERVICE SINCE PURCHASE IN 2008. THE INSPECTION FOUND THAT THE DEVICE'S MASTER BLADE WAS NOT FLUSH WITH THE CONTROL BAR, THE MOTOR RPMS WERE OUT OF SPECIFICATION AND THE THICKNESS CONTROL LEVER SETTINGS WERE OUT OF SPECIFICATIONS. THE LIKELY CAUSE OF THE REPORTED COMPLAINT IS AN OUT OF CALIBRATION DEVICE, 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 WOULD NOT TAKE GRAFT OFF IN ONE PIECE. 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 KIT AIR DERMATOME KIT GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1