BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2982317 · Received January 25, 2013

    Report

    Report Number
    3003793491-2013-00232
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS RECEIVED THE DEVICE ASSOCIATED WITH THIS REPORT; HOWEVER, THE DEVICE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 3 SEPARATE EVENTS, THE PLATFORM POWERED OFF DURING ARRESTS. CUSTOMER SWAPPED THE BATTERIES AND THE PROBLEM CONTINUED. CUSTOMER ALSO INDICATED THAT THE ISSUE OCCURRED WHILE USING PLATFORM SN (B)(4). THERE IS NO INFO ABOUT OTHER 2 EVENTS, DELAY IN TREATMENT, OR THE PT OUTCOME. EVENT 1: MFR REPORT# 3003793491-2013-00230. EVENT 2: MFR REPORT# 3003793491-2013-00231. EVENT 3: MFR REPORT# 3003793491-2013-00232.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35918 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other