BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY FOR BATTERY POWER LINE

    MDR report key: 3140225 · Received May 31, 2013

    Report

    Report Number
    8030965-2013-02559
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 12, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MOQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING A SURGICAL PROCEDURE ON (B)(6) 2013, THE BATTERY WAS NOT WORKING. A SPARE BATTERY WAS READILY AVAILABLE AND WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM, AND WITH NO ADVERSE EVENT TO PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR A BATTERY FOR BATTERY POWER LINE. THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242014 BATTERY FOR BATTERY POWER LINE MOQ SYNTHES GMBH D120222

    Patients

    Seq Age Sex Outcome Treatment
    1