BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION MODEL 100

    MDR report key: 6056195 · Received October 25, 2016

    Report

    Report Number
    3010617000-2016-00761
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    October 4, 2016
    Report Date
    June 30, 2017
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    UDI-DI
    00849111001823
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WILL NOT BE RETURNED FOR INVESTIGATION. THEREFORE, A PHYSICAL INVESTIGATION WILL NOT BE PERFORMED. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    FOLLOWING CUSTOMER'S APPROVAL TO HAVE THE AUTOPULSE PLATFORM SERVICED, THE PROCESSOR BOARD WAS REPLACED TO RESOLVE THE "SYSTEM ERROR" ISSUE. UNRELATED TO THE ISSUE, THE BATTERY PARTITION COVER WAS ALSO REPLACED. THE PLATFORM WAS FURTHER TESTED AND PASSED ALL FINAL TESTING CRITERIA.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S REPORTED COMPLAINT OF AUTOPULSE PLATFORM DISPLAYING SYSTEM ERROR UPON POWER UP WAS CONFIRMED DURING FUNCTIONAL TESTING AND WAS ATTRIBUTE TO A DEFECTIVE PROCESSOR BOARD. DURING FUNCTIONAL TESTING, THE AUTOPULSE PLATFORM DISPLAYED UA 136 (INTERNAL PARAMETER CORRUPTED) UPON POWER UP. A REVIEW OF THE PLATFORM ARCHIVE COULD NOT BE PERFORMED AS THE DATA WAS CORRUPTED. A VISUAL INSPECTION OF THE RETURNED AUTOPULSE PLATFORM WAS PERFORMED AND FOUND NO PHYSICAL DAMAGES TO THE DEVICE. THE PLATFORM WAS NOT REPAIRED AS THE CUSTOMER IS REPLACING THEIR PLATFORMS. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO SIMILAR HISTORY OF COMPLAINT REPORTED FOR AUTOPULSE WITH SERIAL NUMBER (B)(4). ON 11/04/2014, THE PLATFORM WAS RETURNED FOR REPAIR DUE TO PHYSICAL DAMAGES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE MORNING SHIFT CHECK, THE AUTOPULSE PLATFORM DISPLAYED A "SYSTEM ERROR" MESSAGE. NO OTHER INFORMATION WAS PROVIDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705277 AUTOPULSE® RESUSCITATION MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100 00849111001823

    Patients

    Seq Age Sex Outcome Treatment
    1