BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 4079227 · Received September 10, 2014

    Report

    Report Number
    3010617000-2014-00456
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON 08/28/2014 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED AND FOUND NO DAMAGES TO THE PLATFORM. THE RETURNED PLATFORM UNDERWENT AND PASSED INITIAL FUNCTIONAL TESTING. THE PLATFORM RAN FOR 45 MINUTES USING ZOLL'S LARGE TEST FIXTURE WITH NO FAULTS OR ERRORS EXHIBITED. A REVIEW OF THE PLATFORM'S ARCHIVE WAS PERFORMED AND DETERMINED THAT THE REPORTED EVENT OF THE PLATFORM EXHIBITING A USER ADVISORY (UA) 8 (MOTOR CONTROLLER FAULT DETECTED) OCCURRED ON (B)(6) 2014 RATHER THAN ON THE REPORTED EVENT DATE OF (B)(6) 2014. ALSO NOTED ON (B)(6) 2014, THE ARCHIVE SHOWS THE FOLLOWING UA'S TO HAVE OCCURRED: UA 2 (COMPRESSION TRACKING ERROR) AND UA 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART). THE ROOT CAUSE FOR THE UA 8 COULD NOT BE DETERMINED AND THE FAULT WAS NOT REPEATED DURING FUNCTIONAL TESTING AT ZOLL. PER THE AUTOPULSE® MAINTENANCE GUIDE (P/N 11653-001), UA 2 OCCURS WHEN THE AUTOPULSE® HAS DETECTED A CHANGE IN LIFEBAND® TENSION. AS THERE WERE NO ISSUES IDENTIFIED DURING FUNCTIONAL TESTING ASSOCIATED WITH UA 2, THE PROBABLE ROOT CAUSE OF THE EXHIBITED UA 2 WAS DETERMINED TO BE A CHANGE IN THE LIFEBAND® TENSION. THE AUTOPULSE® WAS DESIGNED TO EXHIBIT UA 2 TO PREVENT PATIENT HARM DUE TO CHANGES IN LIFEBAND® TENSION. PER THE AUTOPULSE TECHNICAL SERVICE GUIDE (P/N 11377-006), UA 45 IS EXHIBITED WHEN THE LIFEBAND IS NOT FULLY EXTENDED, OR THE ENCODER IS NOT IN THE "HOME" POSITION. AS THERE WERE NO ISSUES IDENTIFIED DURING FUNCTIONAL TESTING ASSOCIATED WITH UA 45, THE PROBABLE ROOT CAUSE OF THE EXHIBITED UA 45 WAS DETERMINED TO BE THAT THE LIFEBAND WAS NOT FULLY EXTENDED, CAUSING THE ENCODER TO NOT BE AT THE "HOME" POSITION. THE AUTOPULSE® WAS DESIGNED TO EXHIBIT UA 45 TO PREVENT PATIENT HARM. NO PARTS WERE REPLACED ON THE PLATFORM RELATED TO THE CUSTOMER'S REPORTED COMPLAINT. THE PLATFORM UNDERWENT AND MET ALL FINAL FUNCTIONAL TESTING CRITERIA. THE CUSTOMER'S REPORTED COMPLAINT OF THE PLATFORM EXHIBITING UA 8 WAS CONFIRMED THROUGH REVIEW OF THE PLATFORM'S ARCHIVES. HOWEVER, THE ROOT CAUSE FOR THE UA 8 COULD NOT BE DETERMINED AND THE FAULT WAS NOT REPEATED DURING FUNCTIONAL TESTING AT ZOLL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHIFT CHECK, THE AUTOPULSE PLATFORM DISPLAYED A USER ADVISORY (UA) 8 (MOTOR CONTROLLER FAULT DETECTED) MESSAGE THAT WAS UNABLE TO BE CLEARED BY POWERING THE DEVICE OFF AND ON. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559201 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1