BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION MODEL 100

    MDR report key: 4573264 · Received March 5, 2015

    Report

    Report Number
    3010617000-2015-00136
    Event Type
    Malfunction
    Date Received
    March 5, 2015
    Date of Event
    February 11, 2015
    Report Date
    February 19, 2015
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 AND NO PHYSICAL DAMAGES WERE OBSERVED. THE AUTOPULSE PLATFORM WAS TURNED ON/OFF WITH NO PROBLEMS OBSERVED. THE REPORTED COMPLAINT WAS NOT OBSERVED DURING FUNCTIONAL TESTING. THE PLATFORM WAS RUN FOR 20 MINUTES USING A LARGE RESUSCITATION TEST FIXTURE (LRTF) AND NO PROBLEMS WERE OBSERVED. THE PLATFORM ALSO UNDERWENT LOAD CELL CHARACTERIZATION TESTING, WHICH CONFIRMED THAT BOTH LOAD CELLS ARE FUNCTIONING PROPERLY. NO SESSIONS WERE RECORDED IN THE ARCHIVE ON THE REPORTED EVENT DATE OF (B)(6) 2015. THE AUTOPULSE ARCHIVE RECORDS UP TO 30 SESSIONS, THEREFORE THE SESSION THAT OCCURRED ON (B)(6) 2015 WAS SUPERSEDED BY CURRENT SESSIONS. THE ARCHIVE HOWEVER DOES SHOW THAT MULTIPLE UA 2 AND 45 FAULTS OCCURRED ON OTHER DATES, MOST RECENTLY (B)(6) 2015. BASED ON THE INVESTIGATION RESULTS, NO PARTS WERE REPLACED TO REMEDY THE CUSTOMER'S REPORTED COMPLAINT OF THE PLATFORM EXHIBITING USER ADVISORIES (UAS) 2 AND 45. THE CUSTOMER'S REPORTED COMPLAINT WAS UNABLE TO BE DUPLICATED DURING FUNCTIONAL TESTING. THE ROOT CAUSE OF BOTH ERRORS WERE UNABLE TO BE DETERMINED. HOWEVER, PER AUTOPULSE TECHNICAL SERVICE GUIDE (P/N 11377-006), A UA2 IS EXHIBITED WHEN THE PLATFORM DETECTS A CHANGE IN LIFEBAND TENSION. THIS ADVISORY HAPPENS WHEN EITHER THE PATIENT OR THE LIFEBAND IS OUT OF POSITION, OR IF THE LIFEBAND IS OPENED DURING ACTIVE OPERATION. UA45 MOST COMMONLY OCCURS WHEN THE LIFEBAND STRAPS ARE NOT FULLY EXTENDED BEFORE PRESSING START. THE PLATFORM UNDERWENT AND PASSED ALL FINAL FUNCTIONAL TESTING.

    Additional Manufacturer Narrative · 1

    THE REPORTED USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) WAS CLEARED WHILE THE CUSTOMER WAS ON THE PHONE WITH ZOLL TECH. SUPPORT REP. ON (B)(4) 2015. AFTER THE UA 45 MESSAGE CLEARED, A UA 2 (COMPRESSION TRACKING ERROR) MESSAGE THEN DISPLAYED. THE CUSTOMER ATTEMPTED MULTIPLE TIMES TO PRODUCE COMPRESSIONS ON A MANNEQUIN WITHOUT SUCCESS. THE DEVICE CONTINUES TO DISPLAY A USER ADVISORY 2 WHICH WILL NOT CLEAR. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CALL, THE AUTOPULSE PLATFORM IMMEDIATELY DID NOT WORK AND DISPLAYED A USER ADVISORY (UA) 2 (COMPRESSION TRACKING ERROR) AND THEN DISPLAYED A USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) MESSAGE. THE PLATFORM DID NOT PERFORM ANY COMPRESSIONS AND THEREFORE WAS NOT USED. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153317 AUTOPULSE® RESUSCITATION MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1