BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 4157740 · Received October 9, 2014

    Report

    Report Number
    3010617000-2014-00515
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON 09/23/2014 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED AND FOUND THE FRONT COVER TO BE CRACKED. THE PLATFORM FAILED INITIAL FUNCTIONAL TESTING AS IT EXHIBITED A USER ADVISORY (UA) 27 (ENCODER FAULT (>3000 RPM)). THE ROOT CAUSE OF THE EXHIBITED UA 27 WAS DETERMINED TO BE A DEFECTIVE ENCODER. ONCE THE ENCODER WAS REPLACED, THE PLATFORM UNDERWENT SEVERAL HOURS OF TESTING USING A 95% TEST FIXTURE WITHOUT EXHIBITING ANY FAULTS OR ERRORS. A REVIEW OF THE PLATFORM'S ARCHIVE WAS PERFORMED AND NO ANOMALIES WERE FOUND ON THE REPORTED EVENT DATE OF (B)(6) 2014. HOWEVER, MULTIPLE UA 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART), UA 12 (LIFEBAND NOT PRESENT), AND UA 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) WERE FOUND TO HAVE OCCURRED ON (B)(6) 2014, THE CLOSEST RECORDED DATE OF CUSTOMER USAGE IN THE ARCHIVE BEFORE THE REPORTED EVENT DATE. PER THE AUTOPULSE TECHNICAL SERVICE GUIDE (P/N 11377-006), UA 7 IS EXHIBITED WHEN THE PATIENT IS NOT PROPERLY ALIGNED ON THE PLATFORM AND UA 12 IS EXHIBITED WHEN THE PLATFORM DETECTS THAT THE LIFEBAND IS NOT PROPERLY INSTALLED. THE AUTOPULSE® WAS DESIGNED TO EXHIBIT UA7 AND UA 12 TO PREVENT PATIENT HARM. NO PARTS NEEDED TO BE REPLACED TO REMEDY THE CUSTOMER'S REPORTED COMPLAINT OF THE PLATFORM EXHIBITING UA 45. UNRELATED TO THE REPORTED COMPLAINT, THE FRONT ENCLOSURE WAS REPLACED. THE PLATFORM ALSO UNDERWENT LOAD CELL CHARACTERIZATION TESTING, WHICH FOUND BOTH LOAD 1 AND LOAD 2 TO BE FUNCTIONING WITHIN SPECIFICATION. THE PLATFORM UNDERWENT AND PASSED ALL FINAL FUNCTIONAL TESTING. THE CUSTOMER'S REPORTED COMPLAINT OF THE PLATFORM EXHIBITING UA 45 WAS CONFIRMED THROUGH REVIEW OF THE PLATFORM'S ARCHIVE. THE ROOT CAUSE WAS DETERMINED TO BE THAT THE LIFEBAND STRAPS WERE NOT PULLED COMPLETELY OUT PRIOR TO TURNING THE DEVICE ON.

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT YET RECEIVED THE AUTOPULSE PLATFORM IN COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE, THE AUTOPULSE PLATFORM PERFORMED 2 COMPRESSIONS, THEN STOPPED AND DISPLAYED A USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) MESSAGE. THE CREW ATTEMPTED TO RESTART THE PLATFORM BUT WAS UNSUCCESSFUL AND THE MESSAGE COULD NOT BE CLEARED. THEY REVERTED TO MANUAL CPR (EXACT LENGTH OF TIME WAS NOT PROVIDED). RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS NEVER ACHIEVED AND THE PATIENT DID NOT SURVIVE. NO FURTHER INFORMATION WAS PROVIDED. MANUFACTURER HAS REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636010 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 MANUAL CPR