BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIV-BATTERY CHARGER F/SYNTHES BATT 2 CH

    MDR report key: 4133201 · Received October 1, 2014

    Report

    Report Number
    8030965-2014-00888
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    July 26, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE POWER SUPPLY WAS NOT FUNCTIONING AND THE MAIN PRINT AND VALVES PRINTS WERE OLD. THIS WAS ATTRIBUTED TO NORMAL WEAR. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2013. THE 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. PLACEHOLDER.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR SERVICE. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED BURN TRACES ON THE CHARGING BAY. THE MAIN PRINT AND VALVE PRINT WERE OLD. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611179 UNIV-BATTERY CHARGER F/SYNTHES BATT 2 CH MOQ SYNTHES GMBH 22624

    Patients

    Seq Age Sex Outcome Treatment
    1