BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIV-BATTERY CHARGER F/SYNTHES BATT 2 CH

    MDR report key: 4143578 · Received October 6, 2014

    Report

    Report Number
    8030965-2014-01017
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    June 17, 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

    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. 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. 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE POWER SUPPLY DID NOT FUNCTION PROPERLY. THIS WAS CONTRIBUTED TO NORMAL WEAR. VARIOUS PARTS WERE REPLACED. DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON 06/18/2013. PLACEHOLDER.

    Description of Event or Problem · 1

    UPON RETURN OF THE DEVICE THE TECHNICIAN FOUND THAT THE POWER SUPPLY WAS DEFECTIVE AND THE CASING WAS BROKEN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623381 UNIV-BATTERY CHARGER F/SYNTHES BATT 2 CH MOQ SYNTHES GMBH 22301

    Patients

    Seq Age Sex Outcome Treatment
    1