BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATT F/NOS. 532.101+532.110

    MDR report key: 3121553 · Received May 21, 2013

    Report

    Report Number
    8030965-2013-02299
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 22, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE PRESENT BATTERY WAS DISMANTLED AND REVIEWED. IT WAS ESTABLISHED THAT THE OVERCURRENT PROTECTION WAS DEFECT. THE EXACT CAUSE OF DAMAGE COULD NOT BE DETERMINED, BUT WE EXCLUDE A FAILURE FROM THE PRODUCTION. PLEASE NOTE THAT EXCLUSIVELY THE SYNTHES UNIVERSAL CHARGER (05.001.204) SHOULD BE USED, WHEN CHARGING THE BATTERY. OTHER CHARGER COULD LEAD TO DAMAGES. THE BATTERY WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. CORRECTED INFORMATION: THE PART AND LOT NUMBER, COMMON DEVICE CODE, AND 510K NUMBER WERE NOT REPORTED CORRECTLY IN THE INITIAL MEDWATCH. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE BATTERY OF THE DEVICE WAS DEFECTIVE. IT IS UNKNOWN WHERE THIS OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224715 BATT F/NOS. 532.101+532.110 HWE SYNTHES GMBH 120914

    Patients

    Seq Age Sex Outcome Treatment
    1