BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3032143 · Received March 6, 2013

    Report

    Report Number
    3003793491-2013-00372
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE, USING LI-ION BATTERIES, STOPPED WORKING AFTER 4-5 COMPRESSIONS ON THE PT. THE BATTERY WAS REPLACED, BUT THE PLATFORM STOPPED AFTER 4-5 COMPRESSIONS AGAIN. PLATFORM DID NOT INDICATE A USER ADVISORY. SERIAL NUMBERS OF 2 LITHIUM BATTERIES ARE (B)(4). NO OTHER INFO WAS PROVIDED. AUTOPULSE SN (B)(4); BATTERY SN (B)(4), MFR REPORT # 3003793491-2013-00373, BATTERY SN (B)(4), MFR REPORT# 3003793491-2013-00374. CUSTOMER DID NOT REPLY TO REQUESTS FOR ADD'L INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96558 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other