BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APD 60.000 RPM

    MDR report key: 4131404 · Received October 1, 2014

    Report

    Report Number
    8030965-2014-00791
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    March 21, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HBB
    PMA / PMN Number
    K093361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, INVESTIGATION REVEALED THE CONTROL VALVE WAS ROUGH RUNNING AND SEIZED DUE TO IMPROPER MAINTENANCE. THERE WAS NO OIL IN DEVICE AND THE VALVE WAS HANGING. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2013. THE COMPLAINT IS INDETERMINATE. (B)(6). PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DEVICE DOES NOT SHUT OFF PROPERLY AND THE OPERATOR WAS INJURED. THIS IS REPORT 1 OF 1 FOR #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612002 APD 60.000 RPM HBB SYNTHES GMBH 1675

    Patients

    Seq Age Sex Outcome Treatment
    1