BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE 12V BATTERY

    MDR report key: 3640092 · Received February 21, 2014

    Report

    Report Number
    2520274-2014-00751
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Report Date
    January 23, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ACTUAL EVENT DATE NOT KNOWN. THE DEVICE IS AN INSTRUMENT, NOT IMPLANTED/EXPLANTED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT BEEN IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. THE MANUFACTURE DATE OF THIS ITEM IS UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS THE DEVICE HAS NOT YET BEEN RETURNED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SERVICE HISTORY WAS REVIEWED FOR THIS DEVICE AND DETERMINED THAT THERE WERE NO PRIOR SERVICE REPORTS. SERVICE RECORD EVALUATION: A PRE-REPAIR DIAGNOSTIC ASSESSMENT DID NOT IDENTIFY A FAILURE MODE. DEVICE OPERATED AS INTENDED. LOT #D130228.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DEVICE NEEDS TO BE SENT IN FOR REPAIR BECAUSE OF DEVICE BATTERY FAILURE. DEVICE HAS A RELATIVELY NEW BATTERY, SINCE (B)(6) 2013, WHICH LOOSES POWER VERY QUICKLY. NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109915 SMALL BATTERY DRIVE 12V BATTERY HWE SYNTHES (USA) D130228

    Patients

    Seq Age Sex Outcome Treatment
    1