BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2983184 · Received January 31, 2013

    Report

    Report Number
    3003793491-2013-00264
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    September 28, 2012
    Report Date
    October 11, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT WAS CONFIRMED. USER ADVISORY 02 (COMPRESSION TRACKING ERROR), USER ADVISORY 27 (ENCODER FAULT (>300RPM) AND USER ADVISORY 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESET) WERE INDICATED DURING THE FIRST COMPRESSION. USER ADVISORY 2 TYPICALLY OCCURS WHEN THE PT IS MISALIGNED ON THE PLATFORM. USER ADVISORY 27 INDICATES THAT THE ENCODER IS FAULT AND USER ADVISORY 45 OCCURS WHEN THE MOTOR'S SHAFT HAS NOT REACHED THE HOME POSITION. ENCODER WAS REPLACED AND THE SHAFT WAS TWISTED BACK TO THE HOME POSITION. PLATFORM PASSED FINAL TEST. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE CONTINUOUSLY STOPPED COMPRESSIONS FOR BATTERY RELATED REASONS. ISSUE COULD NOT BE DUPLICATED USING OTHER BATTERIES. ARCHIVE FILE INDICATES THAT THERE ERRORS OCCURRED ON (B)(6) 2011, (B)(6) 2012 AND (B)(6) 2012. EVENT 1, (B)(6)2011, MFR REPORT: 3003793491-2013-00077. EVENT 2, (B)(6) 2012, MFR REPORT: 3003793491-2013-00078. EVENT 3, (B)(6) 2012, MFR REPORT: 3003793491-2013-00079. IT WAS ALSO REPORTED THAT THE PLATFORM INDICATED USER ADVISORY 02 (COMPRESSION TRACKING ERROR), USER ADVISORY 27 (ENCODER FAULT (>300RPM) AND USER ADVISORY 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESET). AUTOPULSE PLATFORM, MFR REPORT # 3003793491-2013-00264. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43835 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other