BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIV-BATTERY CHARGER F/SYNTHES BATT 4 CH

    MDR report key: 3962653 · Received July 29, 2014

    Report

    Report Number
    8030965-2014-00495
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    November 28, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    MOQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO (B)(4) 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, THERE WAS A PROBLEM WITH THE CHARGING BAYS. DEVICE SENT TO (B)(4) FOR REPAIR/REPLACEMENT. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DEVICE WAS NOT CHARGING PROPERLY. THIS IS REPORT 1 OF 1 FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441113 UNIV-BATTERY CHARGER F/SYNTHES BATT 4 CH MOQ SYNTHES GMBH 46504

    Patients

    Seq Age Sex Outcome Treatment
    1