BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2881780 · Received November 7, 2012

    Report

    Report Number
    3003793491-2012-00258
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EXPERIENCE WAS MOST LIKELY DUE TO THE USE OF A BATTERY THAT WAS NOT PROPERLY MAINTAINED. COMPLAINT OF OBSERVING UA2 (COMPRESSION TRACKING ERROR) AND 21 (POSITION CHANGE DOES NOT COINCIDE WITH MOTOR DIRECTION) WAS VERIFIED IN THE ARCHIVE FILE. HOWEVER, THESE USER ADVISORIES WERE NOT GENERATED WHEN THE BOARD WAS TESTED IN THE LAB WITH A MANIKIN AND WITH THE LARGE RESUSCITATION TEST FIXTURE (EQUAL TO A 250 POUND PT). ARCHIVE FILE INDICATED THAT ONLY ONE BATTERY (SERIAL# (B)(4)), WHICH WAS NOT MAINTAINED PROPERLY, WAS USED WITH THE SYSTEM. THE BATTERY WAS LEFT IN THE SYSTEM FOR A FEW DAYS INSTEAD OF BEING REMOVED AT THE END OF EACH SHIFT AND AS INSTRUCTED IN THE AUTOPULSE BATTERY MAINTENANCE PROGRAM GUIDE. THEREFORE, THE MOST LIKELY CAUSE FOR THE REPORTED EVENT IS THE USE OF A BATTERY THAT WAS NOT PROPERLY MAINTAINED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY WERE NOT ABLE TO CLEAR USER ADVISORIES (UA) 2 AND 21. 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 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other