BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2934697 · Received December 21, 2012

    Report

    Report Number
    3003793491-2012-00610
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MED CORPORATION HAS REC'D THE DEVICE ASSOCIATED WITH THIS REPORT. HOWEVER, THE DEVICE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POWER LEVEL OF THE BATTERY SN (B)(4) WAS TOO LOW. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other