BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 4103583 · Received September 19, 2014

    Report

    Report Number
    3010617000-2014-00472
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED PLATFORM SHOWS THAT THE ENCODER COVER WAS DAMAGED. THE PHYSICAL DAMAGE FOUND DURING VISUAL INSPECTION IS NOT RELATED TO THE REPORTED EVENT. THE DAMAGE APPEARS TO HAVE BEEN CAUSED BY NORMAL WEAR AND TEAR. A REVIEW OF THE AUTOPULSE ARCHIVE WAS PERFORMED AND THE ARCHIVE DATA SHOWS THAT NO SESSIONS OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE WAS CONFIRMED. IT WAS FOUND THAT THE DISPLAY WAS ON BOOT MODE. THE FIRMWARE WAS REINSTALLED TO REMEDY THIS ISSUE. IT WAS ALSO OBSERVED THAT THE PLATFORM DISPLAYED A SYSTEM ERROR (ERROR CODE 132- INTERNAL WATCHDOG TIMEOUT) MESSAGE. BASED ON THE INVESTIGATION, THE PART IDENTIFIED FOR REPLACEMENT WAS THE ENCODER COVER. IN SUMMARY, THE REPORTED COMPLAINT WAS CONFIRMED DURING FUNCTIONAL TESTING. THE FAULT FOR DISPLAY OF LINES AND DISTORTED CHARACTERS WAS FOUND TO BE DUE TO THE FIRMWARE. THE ROOT CAUSE FOR SYSTEM ERROR COULD NOT BE DETERMINED. UPON REPLACEMENT OF THE ENCODER COVER, THE PLATFORM WAS RE-EVALUATED THROUGH FUNCTIONAL TESTING AND THE PLATFORM PASSED ALL TESTING CRITERIA.

    Additional Manufacturer Narrative · 1

    PRODUCT IN COMPLAINT WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2014 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A SHIFT CHECK, THE LCD DISPLAY OF AUTOPULSE® PLATFORM EXHIBITED LINES AND DISTORTED CHARACTERS UPON POWER UP. CUSTOMER EXCHANGED THE BATTERY AND REPOWERED THE PLATFORM, HOWEVER, THE LCD DISPLAY NOW SHOWS A "SYSTEM ERROR". THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582276 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1