BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3872377 · Received June 13, 2014

    Report

    Report Number
    3003793491-2014-00285
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER ALSO REPORTED THAT WHEN THE DEVICE WAS TESTED WITH A MANNEQUIN, THE LIFEBAND WOULD PERFORM TAKE UP, HOWEVER A USER ADVISORY 7 MESSAGE WOULD STILL DISPLAY. THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND NO EXTERNAL DAMAGES WERE OBSERVED. A USER ADVISORY 7 MESSAGE (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) WAS DISPLAYED UPON POWER UP OF THE PLATFORM. FURTHER INSPECTION CONFIRMED THAT THE CAUSE WAS A DEFECTIVE LOAD CELL MODULE. DURING FUNCTIONAL TESTING, A USER ADVISORY 27 (ENCODER FAULT, > 3000RPM) FAULT, UNRELATED TO THE REPORTED COMPLAINT, WAS ALSO DISPLAYED. INSPECTION DETERMINED THE CAUSE OF THE UA 27 TO BE A DEFECTIVE POWER DISTRIBUTION BOARD. A REVIEW OF THE ARCHIVE SHOWED THAT A UA 7 MESSAGE WAS DISPLAYED ON THE REPORTED EVENT DATE OF (B)(6) 2014. BASED ON THE INVESTIGATION, THE PART(S) IDENTIFIED FOR REPLACEMENT WERE THE DEFECTIVE LOAD CELL AND POWER DISTRIBUTION BOARD. IN SUMMARY, THE REPORTED COMPLAINT WAS CONFIRMED DURING ARCHIVE REVIEW AS WELL AS FUNCTIONAL TESTING. THE FAULT WAS FOUND TO BE DUE TO A DEFECTIVE LOAD CELL. A UA 27 FAULT WAS ALSO DISPLAYED WHILE TESTING THE PLATFORM. THE UA 27 WAS ATTRIBUTED TO A DEFECTIVE POWER DISTRIBUTION BOARD. FOLLOWING REPLACEMENT OF THE FAILED LOAD CELL AND POWER DISTRIBUTION BOARD, THE DEVICE PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT AFTER THE LIFEBAND® WAS REPLACED AND THE AUTOPULSE® WAS BEING RETURNED TO SERVICE, THE PLATFORM DISPLAYED A USER ADVISORY (UA) 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE UPON POWER UP. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349407 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1