BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3831286 · Received May 23, 2014

    Report

    Report Number
    3003793491-2014-00255
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT THE BATTERY WAS ALSO CHANGED OUT ON THE MORNING OF THE REPORTED EVENT. THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL (B)(4) ON (B)(4) 2014 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED AND FOUND THE LOAD PLATE COVER TO BE TORN, THE LCD SCREEN TO BE FLICKERING, AND THE SHORT BLACK COVER TO BE TORN. FUNCTIONAL TESTING OF THE PLATFORM WAS PERFORMED AND FOUND THE PLATFORM TO FUNCTION CORRECTLY UPON START-UP; HOWEVER, THE PLATFORM WOULD NOT RESTART COMPRESSIONS IN 30:2 MODE AFTER PAUSING FOR BREATHS TO BE ADMINISTERED TO THE MANNEQUIN. THE PLATFORM ALSO EXHIBITED A USER ADVISORY (UA) 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION). A REVIEW OF THE PLATFORM'S ARCHIVES WAS PERFORMED AND FOUND MULTIPLE UA 17, WARNING 1 (LOW BATTERY WARNING), UA 2 (COMPRESSION TRACKING ERROR), UA 12 (LIFEBAND NOT PRESENT), AND UA 18 (MAX TAKE-UP REVOLUTIONS EXCEEDED) MESSAGES, ALL TO HAVE OCCURRED DURING THE REPORTED EVENT ON (B)(4) 2014. THE ARCHIVE ALSO SHOWS THAT BATTERY WITH (B)(4), THE FIRST BATTERY USED DURING THE REPORTED EVENT, WAS NOT FULLY CHARGED DURING USE, WHICH ATTRIBUTED TO THE PLATFORM EXHIBITING WARNING 1 (LOW BATTERY WARNING), AND MAY ALSO HAVE CONTRIBUTED TO THE UA17'S EXHIBITED. BATTERY WITH (B)(4), THE SECOND BATTERY USED, WAS ALSO NOT FULLY CHARGED WHEN PLACED INTO THE PLATFORM, AND WAS ALSO ATTRIBUTED TO THE PLATFORM EXHIBITING WARNING 1 (LOW BATTERY WARNING) A SECOND TIME, AND WAS IN USE WHEN THE PLATFORM EXHIBITED UA2'S WHICH MAY BE DUE TO THE PATIENT MOVING/SHIFTING OUT OF POSITION. THE UA12'S CAN BE ATTRIBUTED TO THE LIFEBAND NOT BEING PROPERLY CLIPPED INTO THE PLATFORM UPON RESTART (THIS USER ADVISORY WAS EXHIBITED WHILE BOTH BATTERIES WITH (B)(4) AND (B)(4)WERE IN USE ON THE PLATFORM). BATTERY WITH (B)(4), WAS THE THIRD AND FINAL BATTERY USED DURING THE EVENT (ALSO NOT FULLY CHARGED) WHEN THE PLATFORM EXHIBITED THE UA18'S. THE UA 18'S APPEAR TO HAVE OCCURRED BECAUSE THERE WAS NO PATIENT PRESENT ON THE PLATFORM WHILE THE LIFEBAND WAS TRYING TO SIZE DOWN. REVIEW OF THE ARCHIVE SHOWS THAT THE CUSTOMER WAS NOT PERFORMING PROPER BATTERY MANAGEMENT, AS BATTERY WITH (B)(4), WHICH WAS USED DURING THE REPORTED EVENT, APPEARS TO HAVE BEEN PLACED INTO THE PLATFORM ON (B)(4) 2014 AND REMAINED THERE WITHOUT BEING CHARGE CYCLED UNTIL USED DURING THE REPORTED EVENT ON (B)(4) 2014. ALSO, AS MENTIONED ABOVE, BATTERIES WITH (B)(4) WERE BOTH PLACED INTO THE PLATFORM FOR USE DURING THE EVENT WITHOUT BEING FULLY CHARGED. THE ARCHIVE ALSO SHOWS BATTERY WITH (B)(4) TO HAVE BEEN PLACED INTO THE PLATFORM ON (B)(4) 2014, NOT FULLY CHARGED, AND REMAINED THERE WITHOUT BEING CHARGE CYCLED UNTIL USED DURING AN EVENT ON (B)(4) 2014. THE MOTOR DRIVE TRAIN WAS REPLACED, REMEDYING THE CUSTOMER'S REPORTED COMPLAINT THAT THE PLATFORM WOULD NOT RESTART AFTER PAUSING FOR BREATHS TO BE DELIVERED TO THE PATIENT. ADDITIONAL WORK COMPLETED NOT RELATED TO THE REPORTED COMPLAINT TO ENSURE THAT THE AUTOPULSE PLATFORM IS FUNCTIONING WITHOUT ISSUES: THE POWER DISTRIBUTION BOARD WAS REPLACED. THE LOAD PLATE COVER, SHORT BLACK COVER AND LCD SCREEN WERE ALSO REPLACED. THE SYSTEM UNDERWENT AND MEETS ALL TESTING CRITERIA. IN CONCLUSION, THE CUSTOMER'S REPORTED COMPLAINT THAT THE PLATFORM WOULD NOT RESTART AFTER PAUSING FOR BREATHS TO BE DELIVERED TO THE PATIENT WAS CONFIRMED THROUGH BOTH FUNCTIONAL TESTING AND REVIEW OF THE ARCHIVE. THE MOTOR DRIVE TRAIN WAS REPLACED, REMEDYING THE CUSTOMER'S REPORTED COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE, THE AUTOPULSE PLATFORM DID NOT RESTART AFTER PAUSING FOR VENTILATION. AFTER A FEW MINUTES OF COMPRESSIONS, THE DEVICE WAS PAUSED FOR VENTILATION BUT WAS UNABLE TO BE RESTARTED. THE CREW PRESSED THE "START/CONTINUE" BUTTON AND THE DEVICE CONTINUED COMPRESSIONS FOR A MINUTE OR SO BEFORE STOPPING AGAIN. THE EXACT FAULT CODES THAT WERE DISPLAYED ON THE PLATFORM ARE UNKNOWN. THE PLATFORM WAS ON A SOLID FLAT SURFACE. CUSTOMER CHECKED THE PATIENT'S POSITION ON THE PLATFORM AND THE POSITION OF THE LIFEBAND ON THE PATIENT. THE BATTERY WAS ALSO CHANGED. NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE PATIENT SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308554 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1