BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE 14.4V BATTERY

    MDR report key: 2978308 · Received February 26, 2013

    Report

    Report Number
    2520274-2013-01111
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 28, 2012
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE HWE. DEVICE MANUFACTURING DATE 05/19/2010. REVIEW OF THE DEVICE HISTORY RECORDS (DHR) REPORTS: THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED (B)(6) 2012 THAT THE BATTERY OF THE SMALL BATTERY DRIVE OF THE 14.4V BATTERY WOULD NOT HOLD A CHARGE FOR MORE THAN 5 MINUTES. NO FURTHER INFORMATION PROVIDED FOR THIS EVENT. THIS IS REPORT 1 OF 1 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82637 SMALL BATTERY DRIVE 14.4V BATTERY SMALL BATTERY DRIVE HWE MD100112

    Patients

    Seq Age Sex Outcome Treatment
    1