BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 4170399 · Received October 14, 2014

    Report

    Report Number
    3010617000-2014-00527
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 18, 2014
    Report Date
    August 21, 2014
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE REPORTED COMPLAINT WAS CONFIRMED; VISUAL INSPECTION WAS PERFORMED AND THE HEAD RESTRAINT WIRE AND BOTTOM ENCLOSURE WERE FOUND TO BE DAMAGED AS WELL THE LOAD PLATE SCREW MISSING. FROM THE CONDITION OF THE RETURNED UNIT, THE DAMAGES APPEAR TO HAVE BEEN DUE TO WEAR AND TEAR. UNRELATED TO THE REPORTED COMPLAINT, A USER ADVISORY 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) WAS DISPLAYED DURING FUNCTIONAL TESTING. FURTHER INSPECTION IDENTIFIED THE CAUSE OF THE UA 7 TO BE A SINGLE POINT LOAD CELL NOT FUNCTIONING PROPERLY. IT WAS ALSO OBSERVED THAT THE PLATFORM WAS NOT GENERATING THE EXPECTED AUDIBLE TONE WHILE PERFORMING COMPRESSIONS. TESTING IDENTIFIED THAT THIS WAS ATTRIBUTED TO THE PROCESSOR BOARD NOT FUNCTIONING PROPERLY. A REVIEW OF THE ARCHIVE SHOWS NO USER ADVISORIES OCCURRING ON THE REPORTED EVENT DATE OF (B)(6) 2014. BASED ON THE INVESTIGATION, THE PART(S) IDENTIFIED FOR REPLACEMENT ARE THE TOP COVER, BOTTOM ENCLOSURE, SINGLE POINT LOAD CELL, AND PROCESSOR BOARD. IN SUMMARY, THE REPORTED COMPLAINT WAS CONFIRMED DURING VISUAL INSPECTION AND ATTRIBUTED TO WEAR AND TEAR. UNRELATED TO THE REPORTED COMPLAINT, A USER ADVISORY 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) WAS DISPLAYED DURING FUNCTIONAL TESTING AND FOUND TO HAVE BEEN CAUSED BY A LOAD CELL NOT FUNCTIONING. THE PROCESSOR BOARD WAS ALSO FOUND TO NOT BE FUNCTIONING PROPERLY, LEADING TO NO AUDIBLE TONE WHEN THE PLATFORM WAS PERFORMING COMPRESSIONS. FOLLOWING SERVICE, THE DEVICE PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING A SHIFT CHECK, THE HEAD RESTRAINT OF AUTOPULSE PLATFORM WAS FOUND TO BE DAMAGED AND THE LOAD PLATE SCREWS WERE MISSING. NO PATIENT INVOLVEMENT WAS REPORTED. THE AUTOPULSE PLATFORM WAS SUBSEQUENTLY RETURNED TO ZOLL FOR INVESTIGATION. DURING INVESTIGATION, THE AUTOPULSE PLATFORM DISPLAYED A USER ADVISORY (UA) 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE. ALTHOUGH THE CUSTOMER DID NOT REPORT THIS, UA 7 IS CONSIDERED A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651751 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1