BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 4681279 · Received April 10, 2015

    Report

    Report Number
    3010617000-2015-00218
    Event Type
    Malfunction
    Date Received
    April 10, 2015
    Date of Event
    March 16, 2015
    Report Date
    March 16, 2015
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED WHICH FOUND THAT THE FRONT ENCLOSURES WERE DAMAGED. THE AUTOPULSE PLATFORM WAS POWERED ON AND A USER ADVISORY 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) WAS DISPLAYED. THE DRIVESHAFT WAS ROTATED BACK TO THE "HOME" POSITION, AND INITIAL FUNCTIONAL TESTING WITH A MANNEQUIN WAS PERFORMED AND NO OTHER ERRORS OR ANOMALIES WERE EXHIBITED. THE PLATFORM ALSO UNDERWENT AND PASSED LOAD CELL CHARACTERIZATION TESTING, WHICH CONFIRMED THAT BOTH LOAD CELLS ARE FUNCTIONING PROPERLY. A REVIEW OF THE ARCHIVE WAS PERFORMED WHICH SHOWED THAT NO ERRORS OR ANOMALIES OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2015, HOWEVER MULTIPLE USER ADVISORIES (UAS) SUCH AS: 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE), 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION) 18 (MAX TAKE-UP REVOLUTIONS EXCEEDED) AND 42 (FORCE OVERLOAD TRIPPED) MESSAGES OCCURRED ON (B)(6) 2015. PER AUTOPULSE TECHNICAL SERVICE GUIDE (P/N 11377-006), A UA7 IS EXHIBITED WHEN THE PLATFORM DETECTS THAT THE PATIENT IS NOT PROPERLY CENTERED. PER AUTOPULSE® MAINTENANCE GUIDE (P/N 11653-001), A UA17 TYPICALLY OCCURS WHEN THE LIFEBAND® IS TWISTED, OR THE BATTERY VOLTAGE IS LOW. AT THE TIME WHEN THE UA 17 OCCURRED, BATTERY (S/N (B)(4)) WAS IN USE WITH THE PLATFORM, WHICH DID NOT HAVE THE PROPER AMOUNT OF VOLTAGE/REMAINING CAPACITY TO FUNCTION PROPERLY (963 RC). THEREFORE, IT IS REASONABLE TO CONCLUDE THAT THE ROOT CAUSE OF THE UA17 WAS THE BATTERY VOLTAGE BEING LOW. PER AUTOPULSE TECHNICAL SERVICE GUIDE (P/N 11377-006), A UA18 IS EXHIBITED WHEN THE AUTOPULSE HAS DETECTED THAT EITHER THE PATIENT'S CHEST IS TOO SMALL WHILE SIZING THE PATIENT (TAKE-UP) OR THAT THERE IS NO PATIENT ON THE PLATFORM. UA42 IS EXHIBITED WHEN THE MAXIMUM AMOUNT OF FORCE HAS BEEN APPLIED DURING COMPRESSIONS. UA45 IS MOST COMMONLY EXHIBITED WHEN THE LIFEBAND STRAPS ARE NOT FULLY EXTENDED BEFORE PRESSING START. A REVIEW OF THE ARCHIVE WAS PERFORMED TO ASSESS THE CUSTOMER'S BATTERY MANAGEMENT PRACTICES. REVIEW OF THE ARCHIVE SHOWS THAT THE CUSTOMER IS NOT PROPERLY MAINTAINING THEIR BATTERIES, NOR PERFORMING DAILY CHECKS OF THE PLATFORM AS RECOMMENDED IN THE IFU. NO PARTS WERE REPLACED TO REMEDY THE CUSTOMER'S REPORTED COMPLAINT. ALL ISSUES NOTED DURING INITIAL FUNCTIONAL TESTING, UNRELATED TO THE REPORTED COMPLAINT, WERE REMEDIED. THE PLATFORM UNDERWENT AND PASSED ALL FINAL FUNCTIONAL TESTING. THE CUSTOMER'S REPORTED COMPLAINT WAS CONFIRMED THROUGH REVIEW OF THE ARCHIVE. THE ROOT CAUSE OF THE COMPLAINT WAS DETERMINED TO BE THAT THE PATIENT WAS MISALIGNED ON THE PLATFORM. THE PLATFORM IS DESIGNED TO EXHIBIT UA'S TO INSTRUCT THE USER THAT THE PATIENT NEEDS TO BE REALIGNED IN ORDER TO PREVENT PATIENT HARM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE, THE AUTOPULSE PLATFORM PERFORMED 3 COMPRESSIONS AND THEN CONSTANTLY DISPLAYED A "REALIGN PATIENT" MESSAGE. THE PATIENT WAS ALIGNED, HOWEVER THE ISSUE WOULD NOT RESOLVE. THE MEDIC REVERTED TO MANUAL CPR (EXACT LENGTH OF TIME WAS NOT PROVIDED). INFORMATION PERTAINING TO THE PATIENT WAS NOT PROVIDED. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240059 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 MANUAL CPR