BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY OSCILLATOR

    MDR report key: 3132462 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02348
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 23, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MOQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A SERVICE HISTORY OF THE PAST SIX MONTHS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. (B)(4).

    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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DEVICE WAS RECEIVED FOR EVALUATION. THE CUSTOMER'S COMPLAINT THAT THIS DEVICE WAS GETTING HOT COULD NOT BE CONFIRMED. THE DEVICE WAS FUNCTIONALLY TESTED AND MET ALL OPERATIONAL SPECIFICATIONS. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED PRIOR TO A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2013, IT WAS DISCOVERED THE BATTERY OSCILLATOR WAS GETTING HOT. THE PROCEDURE WAS COMPLETED BY UTILIZING A SPARE DEVICE. IT WAS ALSO REPORTED THERE WAS NO PATIENT INVOLVEMENT WHEN THE EVENT OCCURRED. THIS REPORT IS FOR A BATTERY OSCILLATOR. 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
    237200 BATTERY OSCILLATOR MOQ SYNTHES GMBH 4464

    Patients

    Seq Age Sex Outcome Treatment
    1