BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2973475 · Received February 16, 2013

    Report

    Report Number
    3003793491-2012-00053
    Event Type
    Death
    Date Received
    February 16, 2013
    Date of Event
    April 14, 2012
    Report Date
    April 20, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE DEVICE (S/N (B)(4)) INVOLVED IN THE EVENTS WAS RETURNED TO ZOLL CIRCULATION ON (B)(6) 2012 AND WAS ANALYZED. THE REPORTED PROBLEMS WERE CONFIRMED. NO BATTERIES WERE SENT BACK FOR EVALUATION WITH THE DEVICE HOWEVER, THE ARCHIVE DATA FILES INDICATED THAT THE CUSTOMER WAS NOT FOLLOWING PROPER BATTERY MANAGEMENT PROCEDURES OF DAILY SYSTEM CHECKS AND BATTERY SWAP. THE MANUFACTURER'S BATTERY MAINTENANCE PROGRAM RECOMMENDS THAT USERS CHANGE BATTERIES DAILY OR AFTER EACH USE. THE ARCHIVE DATA ALSO SHOWED MULTIPLE USER ADVISORY MESSAGES THAT HAD OCCURRED INCLUDING: UA 44 (BATTERY VOLTAGE TOO LOW DURING COMPRESSION), UA 2 (COMPRESSION TRACKING ERROR), AND UA18 (MAX TAKE-UP REVOLUTIONS EXCEEDED). THE ARCHIVE DATA ALSO INDICATES THAT THE DEVICE WAS NEVER USED ON THE DATE INCIDENT REPORTED. ON (B)(6) 2012, BATTERIES S/N (B)(4) EXHIBITED LOW VOLTAGE AND BEING USED REPEATEDLY ON THE PLATFORM. NO LOAD CHANGE WAS DETECTED AT THE LOAD PLATE. THE DEVICE WAS RUN FOR ONE HOUR WITH A KNOWN GOOD BATTERY ON 95% PT TEST FIXTURE WITH NO FAULTS OR ERRORS. LOAD CELL CHARACTERIZATION CONFIRMED BOTH LOAD CELL MODULES ARE NOMINAL. PROBABLE ROOT CAUSES FOR THE UNIT DISPLAYING USER ADVISORY MESSAGES OF UA 2 AND UA 18 COULD POSSIBLY BE DUE TO NOT ENOUGH WEIGHT APPLIED TO THE LOAD PLATE AND/OR THE PT WAS MISALIGNED ON THE PLATFORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE POWERED OFF AFTER RUNNING FOR 30 COMPRESSIONS. ANOTHER BATTERY WAS INSTALLED WHICH ALSO RAN FOR 30 COMPRESSIONS AND THEN POWERED OFF. THIS HAPPENED ON 2 SEPARATE PTS. MANUAL CPR WAS USED ON THE FIRST PT, WHEREBY THE PT EXPIRED. IT WAS DETERMINED THAT THIS INCIDENT WAS NOT ATTRIBUTED TO THE USE OF THE DEVICE. THE SECOND PT WAS REPORTED TO HAVE SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69898 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O