BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3734744 · Received April 8, 2014

    Report

    Report Number
    3003793491-2014-00181
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IN COMPLAINT WAS RETURNED TO ZOLL CIRCULATION ON (B)(6) 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 ANALYSIS. VISUAL INSPECTION OF THE RETURNED PLATFORM SHOWS NO DAMAGES TO THE PLATFORM. REVIEW OF THE ARCHIVE WAS PERFORMED AND IT SHOWS NO SESSIONS OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE THAT "THE PLATFORM DOES NOT POWER ON WITH GOOD KNOWN WORKING BATTERIES" WAS ABLE TO BE REPRODUCED. THE PLATFORM POWERED UP WITH A NIMH BATTERY, HOWEVER, IT WOULD NOT POWER UP WITH A LI-ION BATTERY. IT WAS FOUND THAT THE POWER DISTRIBUTION BOARD WAS AT FAULT. BASED ON THE INVESTIGATION, THE PART IDENTIFIED FOR REPLACEMENT WAS THE POWER DISTRIBUTION BOARD. IN SUMMARY, THE REPORTED COMPLAINT THAT "THE AUTOPULSE PLATFORM DOES NOT POWER ON WITH GOOD KNOWN WORKING BATTERIES" WAS CONFIRMED DURING FUNCTIONAL TESTING. THE FAULT WAS FOUND TO BE DUE TO THE DEFECTIVE POWER DISTRIBUTION BOARD. UPON REPLACEMENT OF THE POWER DISTRIBUTION BOARD, THE PLATFORM PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING INCOMING INSPECTION, THE AUTOPULSE PLATFORM WOULD NOT POWER ON, WHEN USED WITH FUNCTIONING BATTERIES. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211128 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1