BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3914476 · Received July 3, 2014

    Report

    Report Number
    3003793491-2014-00321
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED PLATFORM SHOWS THAT THE SCREW POST ON THE TOP COVER, HEAD RESTRAINT ASSEMBLY (HEAD STRAP CABLES), ENCODER COVER, RESTRAINT PIN ASSEMBLY, AND THE MOTOR COVER WERE DAMAGED AND THE BATTERY PARTITION COVER WAS MISSING. THE PHYSICAL DAMAGES FOUND DURING VISUAL INSPECTION ARE NOT RELATED TO THE REPORTED EVENT OF THE PLATFORM WILL NOT POWER UP WITH A KNOWN GOOD BATTERY. THE DAMAGES APPEAR TO HAVE BEEN CAUSED BY NORMAL WEAR AND TEAR (AUTOPULSE MANUFACTURED IN 3/2006). A REVIEW OF THE ARCHIVE WAS PERFORMED AND THE REPORTED COMPLAINT WAS NOT CONFIRMED. THE ARCHIVE DATA SHOWS THAT NO SESSIONS OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. THE ARCHIVE ALSO SHOWS THAT THE LAST TIME THE PLATFORM WAS POWERED ON WAS (B)(6) 2014. ON THIS DATE, IT WAS OBSERVED THAT THE PLATFORM RAN FOR 30 MINUTES AND PERFORMED 2049 COMPRESSIONS BEFORE THE FAULTS WARNING 1 - LOW BATTERY WARNING AND USER ADVISORY 4 - BATTERY CHARGE STATE TOO LOW (REPLACE BATTERY) OCCURRED. THE USER ADVISORIES OBSERVED ARE NOT RELATED TO THE REPORTED COMPLAINT. FUNCTIONAL TESTING WAS PERFORMED AND THE CUSTOMER'S REPORTED ISSUE COULD NOT BE REPRODUCED. THE PLATFORM POWERED UP WITH THE TEST BATTERIES. THE PLATFORM WAS ALSO RUN FOR 10 MINUTES WITH THE TEST MANNEQUIN AND AN ADDITIONAL 7 MINUTES WITH A LRTF (LARGE RESUSCITATION TEST FIXTURE) AND NO PROBLEMS WERE FOUND. BASED ON THE INVESTIGATION, THE PARTS IDENTIFIED FOR REPLACEMENT WERE THE TOP COVER, HEAD RESTRAINT ASSEMBLY, ENCODER COVER, MOTOR COVER, RESTRAINT PIN ASSEMBLY, AND THE BATTERY PARTITION COVER. IN SUMMARY, THE REPORTED COMPLAINT "OF THE UNIT NOT POWERING ON" WAS NOT CONFIRMED BASED ON THE ARCHIVE REVIEW AND FUNCTIONAL TESTING. THE PHYSICAL DAMAGE OF THE HEAD RESTRAINT ASSEMBLY CONFIRMED THE REPORTED ISSUE OF THE HEAD STRAP CABLES BEING LOOSE. THE CAUSE WAS FOUND TO BE DUE TO NORMAL WEAR AND TEAR. THE OTHER PHYSICAL DAMAGES OF THE SCREW POST ON THE TOP COVER, ENCODER COVER, MOTOR COVER, AND THE BATTERY PARTITION COVER FOUND DURING VISUAL INSPECTION ARE UNRELATED TO THE REPORTED COMPLAINT. UPON REPLACEMENT OF ALL THE DAMAGED PARTS, THE PLATFORM PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A SHIFT CHECK, THE AUTOPULSE® PLATFORM WOULD NOT POWER UP WITH A "GOOD" BATTERY. CUSTOMER ALSO REPORTED THAT THE HEAD RESTRAINTS APPEARED TO BE LOOSE. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389359 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1