BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3945522 · Received July 21, 2014

    Report

    Report Number
    3003793491-2014-00370
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM S/N 20646R WAS RETURNED TO ZOLL MEDICAL FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED AND FOUND THAT THE TOP COVER AND FRONT ENCLOSURE WERE CRACKED AND THE BATTERY LOCK WAS BENT. INITIAL FUNCTIONAL TESTING OF THE PLATFORM WAS PERFORMED AND NO FAULTS OR ERRORS WERE OBSERVED. A REVIEW OF THE ARCHIVE WAS PERFORMED WHICH SHOWS THAT THE PLATFORM EXHIBITED UA 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) MESSAGES ON THE REPORTED EVENT DATE OF (B)(6) 2014. A ROOT CAUSE OF THE UA45 ERRORS COULD NOT BE DETERMINED, HOWEVER THE MOST LIKELY CAUSE OF THE ERRORS WAS THAT THE LIFEBAND WAS NOT PROPERLY PULLED UP PRIOR TO USE. BASED ON THE INVESTIGATION, THE PARTS IDENTIFIED FOR REPLACEMENT WERE THE TOP COVER, FRONT ENCLOSURE AND BATTERY LOCK. IN SUMMARY THE CUSTOMER'S REPORTED COMPLAINT OF THE PLATFORM HAVING A CRACK ON THE BACK WAS CONFIRMED THROUGH VISUAL INSPECTION OF THE SYSTEM. A REVIEW OF THE ARCHIVE WAS PERFORMED AND IT SHOWED THAT USER ADVISORY 45 MESSAGES OCCURRED ON THE REPORTED EVENT DATE. FOLLOWING SERVICE, INCLUDING REPLACEMENT OF THE DAMAGED PARTS, THE DEVICE PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING A SHIFT CHECK THE AUTOPULSE PLATFORM HAD A CRACK ON THE BACK BOARD. NO PATIENT INVOLVEMENT WAS REPORTED. THE AUTOPULSE PLATFORM WAS SUBSEQUENTLY RETURNED TO ZOLL FOR INVESTIGATION. DURING INVESTIGATION, A USER ADVISORY 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) MESSAGE WAS OBSERVED IN THE ARCHIVE ON THE REPORTED EVENT DATE. ALTHOUGH THE CUSTOMER DID NOT REPORT THIS, UA 45 IS CONSIDERED A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425003 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1