BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE¿ RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3251131 · Received July 29, 2013

    Report

    Report Number
    3003793491-2013-00757
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL CIRCULATION HAS RECEIVED THE PRODUCT IN COMPLAINT AND A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND CONFIRMED DAMAGES TO THE FOLLOWING: HEAD RESTRAINT ASSEMBLY, MOTOR COVER, RESTRAINT PIN ASSEMBLY. THE BATTERY PARTITION COVER WAS ALSO OBSERVED TO BE MISSING. A DEFINITIVE CAUSE FOR THE VISUAL ANOMALIES COULD NOT BE DETERMINED BASED ON THE INVESTIGATION. A REVIEW OF THE ARCHIVE WAS PERFORMED AND CONFIRMED MULTIPLE OCCURRENCES OF USER ADVISORY 41 (PATIENT TEMPERATURE SENSOR FAILURE) MESSAGES. FUNCTIONAL TESTING WAS PERFORMED AND THE UA 41 MESSAGE WAS ALSO OBSERVED WHILE THE PLATFORM WAS PERFORMING COMPRESSIONS ON A TEST FIXTURE. FURTHER INSPECTION OF THE PLATFORM CONFIRMED THAT A FAILED TEMPERATURE SENSOR LED TO THE OBSERVED UA 41 MESSAGES, HOWEVER A DEFINITIVE CAUSE FOR THE WHY THE SENSOR FAILED COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHIFT CHECK THE AUTOPULSE RESUSCITATION SYSTEM DISPLAYED A USER ADVISORY UA 41 (PATIENT TEMPERATURE SENSOR FAILURE) MESSAGE THAT COULD NOT BE CLEARED. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351669 AUTOPULSE¿ RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1