BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 3003684 · Received February 11, 2013

    Report

    Report Number
    3003793491-2013-00301
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT YET RECEIVED THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND WHEN IT IS EVALUATED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DELIVERING COMPRESSIONS, PLATFORM STOPPED COMPRESSION WITHOUT WARNING. TWO BATTERIES WERE TRIED WITH THE SAME RESULT. MANUAL CPR WAS ADMINISTERED. NO ADVERSE EVENT REPORTED. AUTOPULSE SN (B)(4): MFR REPORT # 3003793491-2013-00297; BATTERY #1 SN (B)(4): MFR REPORT # 3003793491-2013-00298; BATTERY #2 SN (B)(4): MFR REPORT #: 3003793491-2013-00299; BATTERY #3 SN (B)(4): MFR REPORT # 3003793491-2013-00300; BATTERY #4 SN: (B)(4): MFR REPORT # 3003793491-2013-00301.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60485 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1