BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2982309 · Received January 25, 2013

    Report

    Report Number
    3003793491-2013-00226
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF PLATFORM SHUTS DOWN AFTER 5 MINS WAS NOT VERIFIED. ARCHIVE FILE SHOWS THAT ON (B)(6) 2012 (THE DATE OF REPORTED EVENT) BATTERY SN (B)(4) WAS USED, BUT IT HAD LOW VOLTAGE DURING COMPRESSIONS. USING THE (B)(4), PLATFORM RAN FOR 25 MINS. USING THE (B)(4), PLATFORM RAN FOR 7 MINS. NO ISSUE WERE OBSERVED IN EITHER TEST. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BATTERIES DO NOT LAST IN THE PLATFORM. EACH BATTERY LASTED 5 MINS AND THE SYSTEM SHUT DOWN. MANUAL CPR WAS ADMINISTERED; PT OUTCOME IS UNK. CUSTOMER IS ALSO SENDING THE BATTERY CHARGER (IN ADDITION TO THE AUTOPULSE PLATFORM) FOR EVAL. NO ADVERSE EVENT REPORTED. AUTOPULSE PLATFORM: MFR REPORT# 3003793491-2013-00226, AUTOPULSE BATTERY CHARGER: MFR REPORT# 3003793491-2013-00229.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35493 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other