BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3885114 · Received June 19, 2014

    Report

    Report Number
    3003793491-2014-00287
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON 07/03/2014 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED PLATFORM SHOWS THAT THE TOP COVER WIRE STRAND WAS BROKEN AND THE LCD IS MISSING PIXELS AND LINES. THE PHYSICAL DAMAGES FOUND DURING VISUAL INSPECTION ARE NOT RELATED TO THE REPORTED EVENT OF THE PLATFORM DISPLAYING A "SYSTEM ERROR, SERVICE OUT OF RANGE" MESSAGE. THE DAMAGES APPEAR TO HAVE BEEN CAUSED BY NORMAL WEAR AND TEAR (AUTOPULSE MANUFACTURED IN JULY OF 2008). A REVIEW OF THE ARCHIVE WAS PERFORMED AND THE REPORTED COMPLAINT OF THE PLATFORM DISPLAYING A "SYSTEM ERROR, SERVICE OUT OF RANGE" MESSAGE WAS CONFIRMED. THE ARCHIVE DATA SHOWS THAT SYSTEM ERROR CODE 139 (UNABLE TO HOLD COMPRESSION POSITION) OCCURRED ON (B)(6) 2014, RATHER THAN ON THE REPORTED EVENT DATE OF (B)(6) 2014. THE ARCHIVE SHOWS THAT NO CLINICAL USE WITH A PATIENT OCCURRED ON THE REPORTED EVENT DATE. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE SYSTEM ERROR MESSAGE. IT WAS FOUND THAT THE DRIVE TRAIN MOTOR BRAKE GAP WAS AT 0.016", WHICH WAS OUT OF SPECIFICATION. THE BRAKE GAP COULD NOT BE ADJUSTED BACK WITHIN THE SPECIFICATION OF 0.008". THE FAULT WAS FOUND TO BE DUE TO A DEFECTIVE DRIVE TRAIN. BASED ON THE INITIAL INVESTIGATION, THE PARTS IDENTIFIED FOR REPLACEMENT WERE THE DRIVE TRAIN MOTOR, TOP COVER, AND THE LCD. IN SUMMARY, THE REPORTED COMPLAINT OF THE PLATFORM DISPLAYING A "SYSTEM ERROR, SERVICE OUT OF RANGE" MESSAGE WAS CONFIRMED BASED ON THE ARCHIVE REVIEW AND UPON FUNCTIONAL TESTING. THE FAULT WAS FOUND TO BE DUE TO THE DEFECTIVE DRIVE TRAIN. THE PHYSICAL DAMAGES FOUND DURING VISUAL INSPECTION ARE UNRELATED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT YET RECEIVED THE AUTOPULSE PLATFORM IN COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE PLATFORM DISPLAYED A "SYSTEM ERROR, SERVICE OUT OF RANGE" MESSAGE. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE INCIDENT OCCURRED DURING DAILY TESTING AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360693 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1