BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 4211147 · Received October 29, 2014

    Report

    Report Number
    3010617000-2014-00579
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    August 13, 2014
    Report Date
    October 6, 2014
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    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. PLEASE SEE THE FOLLOWING RELATED MFR. REPORT #3010617000-2014-00580 FOR AUTOPULSE® LI-ION BATTERY WITH SN: (B)(4).

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM WAS RETURNED TO ZOLL ON 11/10/2014 FOR INVESTIGATION. PLEASE NOTE THAT LI-ION BATTERY WITH S/N (B)(4) WAS NOT RETURNED FOR EVALUATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION WAS PERFORMED AND INDICATED THAT THE LOAD PLATE COVER WAS TORN AND THE TOP COVER WIRE STRANDS HAD BEEN CUT. FROM THE CONDITION OF THE PLATFORM, THE DAMAGES APPEAR TO HAVE BEEN DUE TO WEAR AND TEAR. FUNCTIONAL TESTING COULD NOT INITIALLY BE PERFORMED DUE TO A JAMMED ENCODER GEARBOX. THE ENCODER'S INNER GEARS WERE DAMAGED PREVENTING THE SHAFT FROM SPINNING FREELY WITHOUT FRICTION. FOLLOWING REPLACEMENT OF THE ENCODER GEARBOX, THE PLATFORM WAS FUNCTIONALLY TESTED AND PERFORMED AS INTENDED. LOAD CELL CHARACTERIZATION WAS ALSO PERFORMED AND CONFIRMED THAT BOTH OF THE LOAD CELL MODULES WERE OPERATING WITHIN SPECIFICATION. A REVIEW OF THE PLATFORM'S ARCHIVE DATA WAS PERFORMED. THERE WERE NO USER ADVISORIES OBSERVED IN THE ARCHIVE FOR THE REPORTED EVENT DATE OF (B)(6) 2014. THE REPORTED INFORMATION FROM THE CUSTOMER INDICATED THAT LI-ION BATTERY (S/N (B)(4)) WAS USED AT THE TIME OF THE REPORTED EVENT. BASED ON THE ARCHIVE DATE, THE LAST TIME THAT THE PLATFORM WAS USED WITH LI-ION BATTERY (S/N (B)(4)) WAS ON (B)(6) 2014. THE ARCHIVE SHOWS MULTIPLE USER ADVISORY (UA) 2 (COMPRESSION TRACKING ERROR) CODES ON THIS DATE. THE CODE IS UNRELATED TO BATTERY FUNCTION AND CAN BE DUE TO PATIENT OR PLATFORM MOVEMENT DURING COMPRESSIONS OR NOT ENOUGH WEIGHT DETECTED ON THE LOAD PLATE DURING COMPRESSIONS OR TRANSPORTATION (IMPROPER LOAD CELL CONNECTION). SINCE LOAD CELL CHARACTERIZATION TESTING VERIFIED THAT BOTH LOAD CELLS WERE OPERATING WITHIN SPECIFICATION, THE LIKELY CAUSE OF THE UA 2 CODES SEEN IN THE ARCHIVE IS PATIENT OR PLATFORM MOVEMENT WHILE THE PLATFORM WAS DEPLOYED. A REVIEW OF THE PLATFORM'S ARCHIVE SHOWED NO ISSUES RELATED TO BATTERY MANAGEMENT. BASED ON THE INVESTIGATION, THE PART(S) IDENTIFIED FOR REPLACEMENT WERE THE LOAD PLATE COVER, TOP COVER, FRONT COVER, BOTTOM COVER AND ENCODER GEARBOX. IN SUMMARY, THE REPORTED COMPLAINT OF THE PLATFORM STOPPING COMPRESSIONS WAS CONFIRMED. THE PLATFORM'S ARCHIVE DATA DOES NOT SHOW THE PLATFORM BEING USED ON THE REPORTED EVENT DATE OF (B)(6) 2014. HOWEVER, THERE IS DATA CONSISTENT WITH REPORTED INFORMATION THAT LI-ION BATTERY (S/N (B)(4)) WAS USED WITH THE PLATFORM. THE ARCHIVE SHOWS THAT THE LAST TIME THE PLATFORM WAS USED WITH THIS BATTERY WAS ON 06/12/2014, AT WHICH TIME THE PLATFORM DISPLAYED MULTIPLE UA 2 CODES. BASED ON THE ARCHIVE DATA AND EVALUATION OF THE PLATFORM SHOWING NO MECHANICAL ISSUES WHICH COULD HAVE CONTRIBUTED TO A COMPRESSION TRACKING ERROR, THE LIKELY CAUSE OF THE UA 2 CODES SEEN IN THE ARCHIVE IS PATIENT OR PLATFORM MOVEMENT WHILE THE PLATFORM WAS DEPLOYED. DURING FUNCTIONAL TESTING, THE PLATFORM WAS ALSO FOUND TO HAVE A JAMMED ENCODER GEARBOX, PREVENTING THE DRIVESHAFT FROM SPINNING FREELY. FOLLOWING SERVICE, INCLUDING REPLACEMENT OF THE DAMAGED PARTS AND ENCODER GEARBOX, THE DEVICE PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE PLATFORM PERFORMED COMPRESSIONS FOR ONLY 7-10 MINUTES WHILE USING AUTOPULSE LI-ION BATTERY WITH SERIAL NUMBER (SN) (B)(4). NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691902 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1