BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 4141285 · Received October 3, 2014

    Report

    Report Number
    3010617000-2014-00504
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ZOLL CIRCULATION
    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

    PRODUCT IN COMPLAINT WAS RETURNED TO ZOLL ON 09/16/2014 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM S/N (B)(4) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED AND FOUND THAT THE FRONT ENCLOSURE AND BATTERY LOCK WERE DAMAGED. THE RETURNED PLATFORM UNDERWENT INITIAL FUNCTIONAL TESTING AND THE CUSTOMER'S REPORTED COMPLAINT WAS NOT OBSERVED. THE PLATFORM HOWEVER, MADE A "SQUEEZING" NOISE WHEN THE LIFEBAND WAS SIZING DOWN AND EXHIBITED USER ADVISORY (UA) 16 (TIMEOUT MOVING TO TAKE-UP POSITION) AND UA26 (DECOMPRESSION TARGET NOT REACHED) MESSAGES. IT WAS DETERMINED THAT THE DRIVETRAIN ASSEMBLY WAS AT FAULT FOR ALL 3 OBSERVED ISSUES. A REVIEW OF THE ARCHIVE WAS PERFORMED WHICH FOUND THAT THE PLATFORM WAS NOT USED ON THE REPORTED EVENT DATE OF (B)(6) 2014 AND DID NOT RECORD ANY EVENT WHERE THE PLATFORM EXHIBITED AN UNCOMMANDED SHUT OFF. BASED ON THE INVESTIGATION RESULTS THE PARTS IDENTIFIED FOR REPLACEMENT WERE THE DRIVETRAIN ASSEMBLY, FRONT ENCLOSURE AND BATTERY LOCK. THE PLATFORM UNDERWENT AND PASSED ALL FINAL FUNCTIONAL TESTING. THE CUSTOMER'S REPORTED COMPLAINT OF THE PLATFORM EXHIBITING AN UNCOMMANDED SHUT OFF WAS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF SUCH AN EVENT IN THE PLATFORM ARCHIVE. IT WAS ALSO UNABLE TO BE DUPLICATED DURING FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A SHIFT CHECK WHEN THE AUTOPULSE® PLATFORM WAS POWERED ON, AN UNCOMMANDED SHUT OFF OCCURRED AFTER THE LIFEBAND SIZED DOWN. CUSTOMER WAS ABLE TO REPLICATE THIS PROBLEM APPROXIMATELY 5 TIMES. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619932 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1