BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3854783 · Received June 6, 2014

    Report

    Report Number
    3003793491-2014-00277
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    July 17, 2012
    Report Date
    July 20, 2012
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL (B)(4) ON (B)(4) 2012 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION WAS PERFORMED AND REVEALED THAT THE LONG BLACK COVER WAS SPLIT/CRACKED. NO OTHER DAMAGES WERE NOTED. AN ARCHIVE REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE REPORTED COMPLAINT WAS CONFIRMED. A WEIGHT CHECK TEST INDICATED THAT ONE LOAD CELL WAS DEFECTIVE. THE LOAD CELL WAS REPLACED, REMEDYING THE REPORTED UA 7 MESSAGE. THE PLATFORM PASSED FUNCTIONAL AND FINAL TESTING. THE PROBABLE CAUSE FOR THE REPORTED COMPLAINT COULD BE DUE TO DAMAGED LOAD CELL CAUSED BY DROPPING/MISHANDLING OR NORMAL WEAR AND TEAR (AUTOPULSE PLATFORM WAS MANUFACTURED IN 2008; AGE: GREATER THAN 4 YEARS).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE PLATFORM DISPLAYED A USER ADVISORY (UA) 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE WITHOUT ANY LOAD ON THE PLATFORM. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331549 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1