BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3771566 · Received April 24, 2014

    Report

    Report Number
    3003793491-2014-00213
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION RESULTS: THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND THE FOLLOWING WAS OBSERVED: THE BATTERY LOCK WAS DAMAGED. FROM THE CONDITION OF THE RETURNED UNIT, THE DAMAGES APPEARED TO BE DUE TO NORMAL WEAR AND TEAR. DURING POWER ON OF THE PLATFORM, UA 7 FAULT (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) WAS DISPLAYED. NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONSTANT UA 7 FAULT. BASED ON OBSERVATION OF THE FAULT, THE REPORTED COMPLAINT WAS CONFIRMED. FURTHER INSPECTION IDENTIFIED THAT THE BOTH LOAD CELLS WERE DAMAGED, LEADING TO THE OBSERVED UA 7 FAULT. A REVIEW OF THE ARCHIVE WAS PERFORMED AND NO FAULTS WERE FOUND TO HAVE OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. THE ARCHIVE DATA DID HOWEVER SHOW THAT MULTIPLE UA 7 FAULTS HAD OCCURRED ON OTHER DATES. BASED ON THE INVESTIGATION, THE PART(S) IDENTIFIED FOR REPLACEMENT WERE THE BATTERY LOCK AND BOTH LOAD CELLS. IN SUMMARY, THE REPORTED COMPLAINT WAS CONFIRMED DURING FUNCTIONAL TESTING AND FOUND TO BE DUE TO BOTH LOAD CELLS BEING DAMAGED. FOLLOWING SERVICE, INCLUDING REPLACEMENT OF THE DAMAGED PARTS, THE DEVICE 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) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE, THAT WAS UNABLE TO BE CLEARED. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249837 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1