BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3982187 · Received August 5, 2014

    Report

    Report Number
    3003793491-2014-00392
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON 08/19/2014 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED PLATFORM SHOWS THAT THE BATTERY LOCK WAS DAMAGED. THE PHYSICAL DAMAGE FOUND DURING VISUAL INSPECTION IS NOT RELATED TO THE REPORTED EVENT OF THE PLATFORM DISPLAYING A USER ADVISORY (UA) 16 (TIMEOUT MOVING TO TAKE-UP POSITION) MESSAGE. THE DAMAGE APPEARS TO HAVE BEEN CAUSED BY NORMAL WEAR AND TEAR (AUTOPULSE MANUFACTURED IN MARCH OF 2012). A REVIEW OF THE AUTOPULSE PLATFORM'S ARCHIVE WAS PERFORMED AND SHOWS THAT NO SESSIONS OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED UA 16 FAULT WAS CONFIRMED. THE UA16 FAULT WAS OBSERVED AT THE VERY FIRST COMPRESSION. IT WAS FOUND THAT THE BRAKE GAP HAD SEIZED. THE BRAKE GAP WAS FREED BY CLEANING IT WITH ALCOHOL. IN ADDITION, A UA 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) FAULT WAS OBSERVED UPON POWER UP OF THE PLATFORM. IT WAS FOUND THAT THE LOAD CELL MODULES WERE AT FAULT. UA 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION) AND UA 27 (ENCODER FAULT (> 3000 RPM)) FAULTS ALSO OCCURRED DURING COMPRESSIONS. IT WAS FOUND THAT THE PROCESSOR BOARD WAS AT FAULT. BASED ON THE INVESTIGATION, THE PARTS IDENTIFIED FOR REPLACEMENT ARE THE PROCESSOR BOARD, LOAD CELL MODULES AND THE BATTERY LOCK. IN SUMMARY, THE REPORTED COMPLAINT OF THE PLATFORM DISPLAYING A USER ADVISORY 16 FAULT WAS CONFIRMED DURING FUNCTIONAL TESTING. THE FAULT WAS FOUND TO BE DUE TO THE BRAKE GAP SEIZING. THE PHYSICAL DAMAGE FOUND DURING VISUAL INSPECTION IS UNRELATED TO THE REPORTED COMPLAINT. THE UA 7, UA 17, AND UA 27 FAULTS OBSERVED DURING TESTING ARE ALSO UNRELATED TO THE REPORTED COMPLAINT. UPON REPLACEMENT OF ALL PARTS, THE PLATFORM WAS RE-EVALUATED THROUGH FUNCTIONAL TESTING AND PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE PLATFORM DISPLAYED A USER ADVISORY 16 (TIMEOUT MOVING TO TAKE-UP POSITION) MESSAGE. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457185 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1