BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAD II

    MDR report key: 4162068 · Received October 10, 2014

    Report

    Report Number
    8030965-2014-01546
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES OUS SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. (B)(6). DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE TRIGGER AND VALVE WERE JAMMED AND THE DEVICE LACKED POWER. THIS WAS ATTRIBUTED TO FAULTY CARE AND MAINTENANCE. THE DEVICE WAS REWORKED, REVISED, AND RETURNED TO THE CUSTOMER ON (B)(4) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR REPAIR/SERVICE WITH THE COMPLAINT THAT "THE TRIGGERS GETS BLOCKED, THE MOTOR DOES NOT STOP." THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643971 CAD II HWE SYNTHES GMBH 29003

    Patients

    Seq Age Sex Outcome Treatment
    1