BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3854810 · Received June 6, 2014

    Report

    Report Number
    3003793491-2014-00269
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 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

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

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON 06/04/2014 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED PLATFORM SHOWS THAT THE LOAD PLATE COVER WAS LOOSE. THE PHYSICAL DAMAGE FOUND DURING VISUAL INSPECTION IS NOT RELATED TO THE REPORTED EVENT OF A "SYSTEM ERROR, SERVICE OUT OF RANGE" ERROR MESSAGE. THE DAMAGE APPEARS TO HAVE BEEN CAUSED BY NORMAL WEAR AND TEAR (AUTOPULSE MANUFACTURED IN NOVEMBER OF 2010). A REVIEW OF THE ARCHIVE WAS PERFORMED AND THE REPORTED COMPLAINT OF A "SYSTEM ERROR, SERVICE OUT OF RANGE" MESSAGE WAS NOT CONFIRMED. THE ARCHIVE SHOWS THAT NO CLINICAL EVENT WITH PATIENT USE OCCURRED ON THE REPORTED EVENT DATE. HOWEVER, THE ARCHIVE DATA SHOWS A CLINICAL EVENT WITH PATIENT USE OCCURRED ON (B)(6) 2014. IT ALSO SHOWS THAT A SYSTEM ERROR CODE 139 (UNABLE TO HOLD COMPRESSION POSITION) OCCURRED ON (B)(6) 2014. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED COMPLAINT WAS CONFIRMED. 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". BOTH OF THE SET SCREWS WOULD NOT LOCK INTO THE ENCODER DIMPLE LOCKING HOLE AND CAUSED THE BRAKE TO DISENGAGE. BASED ON THE INITIAL INVESTIGATION, THE PARTS IDENTIFIED FOR REPLACEMENT WERE THE DRIVE TRAIN MOTOR AND THE LOAD PLATE COVER. IN SUMMARY, THE REPORTED COMPLAINT OF A "SYSTEM ERROR, SERVICE OUT OF RANGE" MESSAGE WAS CONFIRMED DURING FUNCTIONAL TESTING. THE FAULT WAS FOUND TO BE DUE TO A DEFECTIVE DRIVE TRAIN MOTOR. THE PHYSICAL DAMAGE FOUND DURING VISUAL INSPECTION IS UNRELATED TO THE REPORTED COMPLAINT.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332943 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1