BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2983182 · Received January 31, 2013

    Report

    Report Number
    3003793491-2013-00074
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    October 17, 2012
    Report Date
    October 17, 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

    BATTERY SN (B)(4) WAS CHARGED AND TEST-CYCLED, RUN-IN TEST WAS PERFORMED WITHOUT ANY ISSUES. ARCHIVE FILE INDICATED THAT LOW VOLTAGE BATTERIES HAD REPEATEDLY BEEN USED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AUTOPULSE FAILURE OCCURRED DURING A CARDIAC ARREST. CUSTOMER INDICATED THAT THE PLATFORM PERFORMED COMPRESSIONS FOR A MINUTE AND POWERED OFF. MANUAL CPR WAS RESUMED. NO ADVERSE EVENT REPORTED. AUTOPULSE PLATFORM AND THREE BATTERIES WERE ALSO RETURNED FOR EVALUATION: AUTOPULSE, MFR REPORT # 3003793491-2013-00073, BATTERY #1, MFR REPORT# 3003793491-2013-00074, BATTERY #2, MFR REPORT# 3003793491-2013-00075, BATTERY #3, MFR REPORT# 3003793491-2013-00076.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43828 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other