BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION MODEL 100

    MDR report key: 4220902 · Received November 3, 2014

    Report

    Report Number
    3010617000-2014-00583
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL SALES REPRESENTATIVE CONFIRMED THE REPORTED COMPLAINT DURING HIS ONSITE VISIT WITH THE CUSTOMER. THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON 10/16/2014 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED PLATFORM SHOWS THAT THE FRONT ENCLOSURE WAS CRACKED AND THE BATTERY LOCK WAS BENT. THE PHYSICAL DAMAGES FOUND DURING VISUAL INSPECTION ARE NOT RELATED TO THE REPORTED COMPLAINT THAT THE PLATFORM PERFORMED COMPRESSIONS FOR ABOUT 5-10 SECONDS AND THEN STOPPED RUNNING ENTIRELY WITH MULTIPLE KNOWN, GOOD FULLY CHARGED LI-ION BATTERIES. THE PHYSICAL DAMAGES OBSERVED DURING VISUAL INSPECTION APPEARS TO HAVE BEEN CAUSED BY NORMAL WEAR AND TEAR (AUTOPULSE MANUFACTURED IN OCTOBER OF 2007). THE REPORTED COMPLAINT WAS NOT REPRODUCED DURING FUNCTIONAL TESTING. THE PLATFORM RAN WITH A LARGE RESUSCITATION TEST FIXTURE (LRTF) FOR ONE HOUR AND NO PROBLEMS WERE OBSERVED. THE PLATFORM PASSED FUNCTIONAL TESTING. A REVIEW OF THE AUTOPULSE PLATFORM'S ARCHIVE DATA WAS PERFORMED AND SHOWS THAT NO SESSIONS OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. A REVIEW OF THE AUTOPULSE PLATFORM'S ARCHIVE DATA WAS PERFORMED TO ASSESS THE CUSTOMER'S BATTERY MANAGEMENT PRACTICES. REVIEW OF THE ARCHIVE SHOWS THAT BATTERIES WITH SERIAL NUMBERS (SN'S) (B)(4) AND (B)(4) WERE NOT FULLY CHARGED AT THE TIME OF USE. THE ARCHIVE DATA SHOWS THAT A USER ADVISORY (UA) 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION) MESSAGE OCCURRED WITH LI-ION BATTERY, SN (B)(4) ON (B)(6) 2014. PER THE AUTOPULSE MAINTENANCE GUIDE (P/N 11653-001), UA 17 IS AN INDICATION THAT THE LIFEBAND IS TWISTED OR THAT THE BATTERY VOLTAGE IS LOW. IN ADDITION, THE ARCHIVE SHOWS THAT A UA 44 (BATTERY VOLTAGE TOO LOW DURING COMPRESSION (REPLACE BATTERY)) MESSAGE OCCURRED WITH NIMH BATTERY, SN (B)(4) ON (B)(6) 2014. PER THE AUTOPULSE MAINTENANCE GUIDE, UA 44 IS AN INDICATION THAT THE BATTERY IS UNCHARGED OR FAULTY. SINCE BOTH OF THE BATTERIES WERE NOT FULLY CHARGED, IT WOULD LIKELY TRIGGER THESE USER ADVISORIES AND CAUSE THE REPORTED COMPLAINT OF THE PLATFORM GIVING COMPRESSIONS FOR ABOUT 5-10 SECONDS AND THEN STOPPING. BOTH OF THESE BATTERIES WERE NOT RETURNED FOR EVALUATION. AN INVESTIGATION CONDUCTED USING THE BATTERIES' SERIAL NUMBERS FOUND THAT LI-ION BATTERY WITH SN (B)(4) WAS WITHIN ITS EXPECTED LIFE SPAN OF 2-4 YEARS AND THAT NIMH BATTERY WITH SN (B)(4) HAD AGED PAST THE END OF ITS USEFUL LIFE. PER THE AUTOPULSE POWER SYSTEM USER GUIDE, EVERY BATTERY SHOULD BE TEST CYCLED EVERY 30 DAYS. GIVEN THAT THE NIMH BATTERY (SN (B)(4)) SHOULD HAVE HAD 42 (+/-1) TEST CYCLES BUT ONLY SHOWED 19 TEST CYCLES, IT CAN BE CONCLUDED THAT THIS BATTERY WAS NOT PROPERLY MAINTAINED. HOWEVER, GIVEN THAT THE LI-ION BATTERY (SN (B)(4)) SHOULD HAVE HAD 19 (+/-1) TEST CYCLES AND SHOWED 19 TEST CYCLES, IT CAN BE CONCLUDED THAT THIS BATTERY WAS PROPERLY MAINTAINED. BASED ON THE INVESTIGATION, THE PARTS IDENTIFIED FOR REPLACEMENT WERE THE FRONT ENCLOSURE AND THE BATTERY LOCK. IN SUMMARY, THE REPORTED COMPLAINT WAS CONFIRMED BASED ON THE PLATFORM'S ARCHIVE REVIEW FOR THE CUSTOMER'S BATTERY MANAGEMENT PRACTICES. THE REPORTED COMPLAINT WAS FOUND TO BE DUE TO THE CUSTOMER USING BATTERIES THAT WERE NOT FULLY CHARGED. THE PHYSICAL DAMAGES FOUND DURING VISUAL INSPECTION ARE UNRELATED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHIFT CHECK, THE AUTOPULSE PLATFORM PERFORMED COMPRESSIONS FOR 5-10 SECONDS AND THEN STOPPED. THE CREW INDICATED THAT THE PLATFORM POWERED ON NORMALLY AND THAT THEY USED MULTIPLE KNOWN, GOOD, FULLY CHARGED LI-ION BATTERIES. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701995 AUTOPULSE® RESUSCITATION MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1