BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 4141337 · Received October 3, 2014

    Report

    Report Number
    3010617000-2014-00506
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IN COMPLAINT WAS RETURNED TO ZOLL ON 09/18/2014 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 WAS PERFORMED AND THE TOP COVER, FRONT ENCLOSURE AND BOTTOM ENCLOSURE WERE CRACKED. FROM THE CONDITION OF THE PLATFORM, THE DAMAGE APPEARS TO HAVE BEEN DUE TO WEAR AND TEAR. THE PLATFORM WAS FUNCTIONALLY TESTED AND THE REPORTED USER ADVISORY 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) WAS VERIFIED UPON POWER UP. FURTHER INSPECTION DETERMINED THE CAUSE TO BE A SINGLE POINT LOAD CELL NOT FUNCTIONING PROPERLY. OTHER THAN THE OBSERVED UA 7 CODE DURING POWER UP, THE PLATFORM PASSED ALL OTHER FUNCTIONAL TESTING. THE PLATFORM WAS RUN WITH A LRTF (LARGE RESUSCITATION TEST FIXTURE) FOR 15 MINUTES AND NO PROBLEMS WERE ENCOUNTERED. THE ARCHIVE SHOWED THE REPORTED UA 7 OCCURRING ON (B)(6) 2014, RATHER THAN ON THE REPORTED EVENT DATE OF (B)(6) 2014. NO OTHER UA CODES WERE OBSERVED ON THE REPORTED EVENT DATE. BASED ON THE INVESTIGATION, THE PARTS IDENTIFIED FOR REPLACEMENT WERE THE TOP COVER, FRONT ENCLOSURE, BOTTOM ENCLOSURE AND SINGLE POINT LOAD CELL. IN SUMMARY, THE REPORTED COMPLAINT OF THE PLATFORM DISPLAYING A UA 7 WAS CONFIRMED DURING POWER UP OF THE DEVICE AS WELL THROUGH ARCHIVE REVIEW. INSPECTION OF THE DEVICE IDENTIFIED THE CAUSE TO BE A SINGLE POINT LOAD CELL NOT FUNCTIONING PROPERLY. FOLLOWING SERVICE, INCLUDING REPLACEMENT OF THE DAMAGED PARTS AND SINGLE POINT LOAD CELL, THE DEVICE PASSED ALL TEST CRITERIA.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A SHIFT CHECK THE AUTOPULSE® PLATFORM DISPLAYED A USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE THAT WAS UNABLE TO BE CLEARED BY POWERING THE DEVICE OFF AND ON. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619875 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1