BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2943147 · Received December 13, 2012

    Report

    Report Number
    3003793491-2012-00489
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    July 31, 2012
    Report Date
    July 31, 2012
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF "LOW RUN TIMES" WAS NOT VERIFIED. PLATFORM WAS RUN FOR 30 MINUTES USING A TEST BATTERY; NO PROBLEMS WERE ENCOUNTERED. ARCHIVE FILE SHOWED A NUMBER OF USER ADVISORY 44'S (BATTERY VOLTAGE TOO LOW DURING COMPRESSION) WHEN BATTERY IDENTIFIED WITH SERIAL NUMBER (B)(4) WAS USED. BASED ON THE INFORMATION IN THE ARCHIVE FILE, THIS BATTERY WAS NOT PROPERLY MAINTAINED (IT WAS NOT TEST CYCLED ON A MONTHLY BASIS)/ PROBABLE CAUSE FOR THE REPORTED LOW RUN TIMES IS IMPROPER BATTERY MAINTENANCE. ONLY THE PLATFORM WAS RETURNED; BATTERY WAS NOT RETURNED FOR EVAL. PLATFORM WOULD TURN ON WHEN THE BATTERY WAS INSERTED. THIS WAS DUE TO THE POWER DISTRIBUTION BOARD, WHICH WAS REPLACED. PLATFORM PASSED FINAL TEST.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LOW RUN TIMES AND THAT AFTER 30 SECONDS, THE PLATFORM DEEMS THE BATTERY LOW MESSAGE. CUSTOMER USED THE SECOND BATTERY AND GOT THE SAME RESULT. NO ADVERSE EVENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other