BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 3063829 · Received March 29, 2013

    Report

    Report Number
    3003793491-2013-00399
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ZOLL CIRCULATION
    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 REC'D THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS REC'D AND WHEN IT IS EVALUATED. NIMH BATTERY S/N (B)(4), MFR REPORT# 3003793491-2013-00399, NIMH BATTERY S/N (B)(4), MFR REPORT# 3003793491-2013-00400 AND 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 ADVISOR 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). NO OTHER INFO COULD BE OBTAINED. THERE WAS NO ADVERSE PT SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129575 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other