BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIV-BATTERY CHARGER F/SYNTHES BATT 4 CH

    MDR report key: 4183230 · Received October 17, 2014

    Report

    Report Number
    8030965-2014-01596
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    October 1, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    MOQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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. 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 A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND NO FAILURE WAS IDENTIFIED. NORMAL SERVICE WAS PERFORMED AND THE DEVICE WAS RETURNED TO THE CUSTOMER ON (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ITEM HAS A FAILURE AND IT WAS FOUND TO BECOME HOT. THIS IS REPORT 1 OF 1 FOR COMPLAINT#(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660564 UNIV-BATTERY CHARGER F/SYNTHES BATT 4 CH MOQ SYNTHES GMBH 44307

    Patients

    Seq Age Sex Outcome Treatment
    1