BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 3063636 · Received March 29, 2013

    Report

    Report Number
    3003793491-2013-00400
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. NIMH BATTERY S/N (B)(4), MFR REPORT # 3003793491-2013-00399. AUTOPULSE PLATFORM S/N (B)(4), MFR REPORT # 3003793491-2013-00401.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON ARRIVAL AT THE SITE, THE PT WAS PUT ON THE AUTOPULSE. THE UNIT SIZED PT, BUT COMPRESSIONS DID NOT START. PLATFORM INDICATED USER ADVISORY 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESET) AT THE SCENE. SHAFT POSITION WAS LATER CHECKED AND FOUND TO BE AT 00000. TWO NIMH BATTERIES WERE INVOLVED IN THIS EVENT. SERIAL NUMBERS ARE (B)(4) AND (B)(4). NO OTHER INFORMATION COULD BE OBTAINED. THERE WAS NO ADVERSE PT SEQUELA REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129738 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other