BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION MODEL 100

    MDR report key: 4467323 · Received January 29, 2015

    Report

    Report Number
    3010617000-2015-00059
    Event Type
    Malfunction
    Date Received
    January 29, 2015
    Date of Event
    January 5, 2015
    Report Date
    January 5, 2015
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS FOR THE RETURNED PLATFORM AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED AND FOUND THAT THE HEAD RESTRAINT BRACKETS, MOTOR COVER AND ENCODER COVER WERE ALL CRACKED AND THE BATTERY PARTITION COVER WAS MISSING. THE SYSTEM WAS TURNED ON/OFF WITH NO PROBLEMS AND RAN USING A 95% PATIENT TEST FIXTURE FOR SEVERAL HOURS WITH NO ANOMALIES OR ERRORS EXHIBITED. A REVIEW OF THE PLATFORM'S ARCHIVE WAS PERFORMED AND FOUND THAT THE PLATFORM WAS LAST USED ON (B)(6) 2014 RATHER THAN ON THE REPORTED EVENT DATE OF (B)(6) 2015. ON THAT DATE, THE PLATFORM EXHIBITED USER ADVISORY (UA) 12 (LIFEBAND NOT PRESENT) AND UA 18 (MAX TAKE-UP REVOLUTIONS EXCEEDED). NO PARTS NEEDED TO BE REPLACED TO REMEDY THE CUSTOMER'S REPORTED COMPLAINT OF THE PLATFORM EXHIBITING A USER ADVISORY MESSAGE (UA 12 OR UA 18). THE PLATFORM UNDERWENT AND PASSED ALL FINAL FUNCTIONAL TESTING. IN SUMMARY, THE CUSTOMER'S REPORTED COMPLAINT OF THE PLATFORM EXHIBITING AN ERROR CODE WAS CONFIRMED THROUGH REVIEW OF THE PLATFORM'S ARCHIVE. PER THE AUTOPULSE TECHNICAL SERVICE GUIDE (P/N 11377-006), UA 12 IS EXHIBITED WHEN THE PLATFORM DETECTS THAT THE LIFEBAND IS NOT PROPERLY INSTALLED. THE MOST LIKELY CAUSE OF THE PLATFORM EXHIBITING UA 12 WAS DETERMINED TO HAVE BEEN MOVEMENT OF THE PATIENT & PLATFORM, CAUSING THE LIFEBAND TO BECOME DETACHED FROM THE PLATFORM. THE AUTOPULSE® WAS DESIGNED TO EXHIBIT UA 12 TO PREVENT PATIENT HARM. THE ROOT CAUSE OF THE EXHIBITED UA 18 WAS DETERMINED TO BE THAT THERE WAS NO SIGNIFICANT LOAD PLACED ON THE PLATFORM. AT THE TIME THAT THE UA 18 OCCURRED, THE ARCHIVE SHOWED THAT THERE WAS NO CHANGE IN THE LOAD. THE AUTOPULSE® WAS DESIGNED TO EXHIBIT UA18 TO PREVENT PATIENT HARM.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON 01/14/2015 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CARDIAC ARREST, THE AUTOPULSE PLATFORM DISPLAYED AN ERROR CODE. CUSTOMER DID NOT KNOW WHAT THE SPECIFIC ERROR CODE WAS. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66647 AUTOPULSE® RESUSCITATION MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1