BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3173453 · Received May 28, 2013

    Report

    Report Number
    3003793491-2013-00622
    Event Type
    Malfunction
    Date Received
    May 28, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON (B)(6) 2013 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION WAS PERFORMED AND REVEALED THAT THE TOP COVER, FRONT ENCLOSURE AND BOTTOM ENCLOSURE OF THE PLATFORM WERE DAMAGED. A DEFINITIVE ROOT CAUSE FOR THE PHYSICAL DAMAGES COULD NOT BE DETERMINED. FUNCTIONAL TESTING WAS PERFORMED AND CONFIRMED A "SERVICE REQUIRED, REVERT TO MANUAL CPR" (ERROR CODE 132 - INTERNAL WATCHDOG TIMEOUT) MESSAGE, THEREBY CONFIRMING THE CUSTOMER'S REPORTED COMPLAINT. THE ERROR MESSAGE WAS CLEARED BY SOFTWARE AP VISION3 AND THE POWER WAS CYCLED (POWERED ON AND OFF) THREE TIMES WITH NO PROBLEMS. REVIEW OF ARCHIVE DATA FILES INDICATED NUMEROUS OCCURRENCES OF FAULT 132; HOWEVER, NO SESSIONS WERE RECORDED ON THE DATE ((B)(6) 2013) OF THE REPORTED INCIDENT. BASED ON THE EVALUATION RESULTS, THE CUSTOMER'S REPORTED COMPLAINT WAS CONFIRMED DURING FUNCTIONAL TESTING. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON POWER UP, THE AUTOPULSE PLATFORM DISPLAYED SERVICE REQUIRED, REVERT TO MANUAL CPR. NO ADVERSE PT SEQUELAE WAS REPORTED. NO FURTHER INFO PROVIDED. MANUFACTURER REQUESTED ADDITIONAL INFO FROM THE CUSTOMER; HOWEVER NO INFO HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233343 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1