BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3900865 · Received June 27, 2014

    Report

    Report Number
    3003793491-2014-00295
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PARAMEDIC

    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 06/30/2014 FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED AND FOUND THE LCD BACKLIGHT TO NOT BE FUNCTIONING. INITIAL FUNCTIONAL TESTING OF THE PLATFORM WAS PERFORMED AND NO FAULTS OR ERRORS WERE EXHIBITED. A REVIEW OF THE ARCHIVE WAS UNABLE TO BE PERFORMED AS THE ARCHIVE WAS UNABLE TO BE DOWNLOADED BECAUSE THE IR AND SERIAL PORTS OF THE PROCESSOR PCA BOARD WERE DEFECTIVE. THE PROCESSOR PCA BOARD WAS REPLACED REMEDYING THE CUSTOMER'S REPORTED COMPLAINT. THE PLATFORM UNDERWENT AND MET ALL FINAL TESTING CRITERIA. THE CUSTOMER'S REPORTED COMPLAINT OF THE LCD BACKLIGHT NOT FUNCTIONING WAS CONFIRMED THROUGH VISUAL INSPECTION OF THE PLATFORM. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE PROCESSOR PCA AT THE LCD BACKLIGHT INPUT. THE PROCESSOR PCA BOARD WAS REPLACED, REMEDYING THE CUSTOMER'S REPORTED COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSPECTION, IT WAS FOUND THAT THE AUTOPULSE PLATFORM'S DISPLAY WAS DAMAGED. NO INFORMATION CAN BE CLEARLY SEEN. OTHER THAN THIS, THE DEVICE WORKS FINE. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376711 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1