BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3854750 · Received June 6, 2014

    Report

    Report Number
    3003793491-2014-00274
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 NO PHYSICAL DAMAGES TO THE PLATFORM, ONLY THE BATTERY LOCK CLIP WAS MISSING. THE MISSING PART FOUND DURING VISUAL INSPECTION IS NOT RELATED TO THE REPORTED COMPLAINT THAT THE PLATFORM SHOWED A USER ADVISORY 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE. FROM THE CONDITION OF THE PLATFORM, THE MISSING BATTERY LOCK CLIP APPEARS TO HAVE BEEN CAUSED BY NORMAL WEAR AND TEAR (AUTOPULSE MANUFACTURED IN 6/2008). A REVIEW OF THE ARCHIVE WAS PERFORMED AND THE REPORTED COMPLAINT THAT THE PLATFORM DISPLAYED A USER ADVISORY 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE WAS CONFIRMED. THE ARCHIVE DATA SHOWS THAT MULTIPLE UA7 MESSAGES OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE THAT THE PLATFORM DISPLAYED A USER ADVISORY 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE WAS CONFIRMED. THE UA7 MESSAGE WAS OBSERVED DURING TESTING. IT WAS FOUND THAT THE LOAD CELL SINGLE POINT WAS AT FAULT. BASED ON THE INVESTIGATION, THE PARTS IDENTIFIED FOR REPLACEMENT ARE THE LOAD CELL AND THE BATTERY LOCK CLIP. IN SUMMARY, THE REPORTED COMPLAINT THAT THE PLATFORM DISPLAYED A USER ADVISORY 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE, WAS CONFIRMED THROUGH THE ARCHIVE REVIEW AND DURING FUNCTIONAL TESTING. THE FAULT WAS FOUND TO BE DUE TO A DEFECTIVE LOAD CELL. THE MISSING PART FOUND DURING VISUAL INSPECTION IS UNRELATED TO THE REPORTED COMPLAINT. UPON REPLACEMENT OF THE LOAD CELL AND THE BATTERY LOCK CLIP, THE PLATFORM PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A SHIFT CHECK, THE AUTOPULSE® PLATFORM DISPLAYED A USER ADVISORY (UA) 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331587 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1