BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 4974442 · Received August 5, 2015

    Report

    Report Number
    3010617000-2015-00438
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 13, 2015
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM WAS RETURNED TO ZOLL (B)(4) FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED AND NO DAMAGES WERE OBSERVED. A REVIEW OF THE AUTOPULSE PLATFORM'S ARCHIVE WAS PERFORMED AND MULTIPLE USER ADVISORIES (UAS) SUCH AS 12 (LIFEBAND NOT PRESENT), 27 (ENCODER FAULT (>3000 RPM)) AND 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) WERE OBSERVED ON THE REPORTED EVENT DATE OF (B)(6) 2015. USER ADVISORY 12 IS AN INDICATION THAT EITHER THERE IS NO LIFEBAND INSTALLED OR THE LIFEBAND IS INSTALLED INCORRECTLY. THE PROBABLE CAUSE ASSOCIATED WITH THIS FAULT IS THAT THE LIFEBAND CLIP ON THE LIFEBAND IS NOT PROPERLY ENGAGING THE SAFETY SWITCH IN THE DRIVESHAFT. PER THE AUTOPULSE MAINTENANCE GUIDE (P/N: 11653-001), THE RECOMMENDED ACTIONS TO TAKE FOR THIS TYPE OF USER ADVISORY ARE: ENSURE THAT THE BAND CLIP (UNDERNEATH THE DEVICE) IS PROPERLY SEATED IN THE DRIVE SHAFT AND THE DRIVE SHAFT CAN FREELY ROTATE AFTER INSERTION. USER ADVISORY 27 IS AN INDICATION THAT THE DRIVESHAFT IS ROTATING TOO FAST. THE PROBABLE CAUSES ASSOCIATED WITH THIS FAULT ARE THAT THE LIFEBAND IS EITHER BEING PULLED UP ON TOO SHARPLY, OR THAT THERE IS AN INTERNAL COMPONENT ERROR OR MALFUNCTION. USER ADVISORY 45 IS AN INDICATION THAT THE DRIVE SHAFT IS NOT AT THE HOME POSITION WHEN THE AUTOPULSE IS POWERED ON. THE PROBABLE CAUSES ASSOCIATED WITH THIS FAULT ARE THAT EITHER THE LIFEBAND WAS CUT BEFORE IT WAS PROPERLY REMOVED, OR THERE IS AN INTERNAL COMPONENT ERROR OR MALFUNCTION. FUNCTIONAL EVALUATION OF THE RETURNED PLATFORM WAS PERFORMED AND THE REPORTED COMPLAINT OF THE AUTOPULSE PLATFORM STOPPING COMPRESSIONS WAS OBSERVED. FURTHER INSPECTION DETERMINED THAT ONE OF THE LOAD CELLS WAS DEFECTIVE. THE REPORTED COMPLAINT OF THE AUTOPULSE PLATFORM DISPLAYING A USER ADVISORY (UA) 27 WAS NOT OBSERVED DURING FUNCTIONAL EVALUATION. BASED ON THE INVESTIGATION, THE PART IDENTIFIED FOR REPLACEMENT WAS THE DEFECTIVE LOAD CELL, HOWEVER, NO PARTS WERE ACTUALLY REPLACED AS THE CUSTOMER DECLINED SERVICE TO THE PLATFORM. IN SUMMARY, THE CUSTOMER'S REPORTED COMPLAINT OF THE PLATFORM STOPPING COMPRESSIONS AND DISPLAYING A USER ADVISORY (UA) 27 WAS CONFIRMED THROUGH REVIEW OF THE ARCHIVE. THE UA 27 WAS NOT DUPLICATED DURING FUNCTIONAL TESTING. THE PLATFORM DID HOWEVER STOP PERFORMING COMPRESSIONS DURING FUNCTIONAL TESTING DUE TO ONE OF THE LOAD CELLS BEING DEFECTIVE. NO DEVICE DEFICIENCIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE MULTIPLE USER ADVISORIES THAT WERE OBSERVED IN THE ARCHIVE. THE LOAD CELL WAS IDENTIFIED FOR REPLACEMENT, HOWEVER, THE CUSTOMER DECLINED REPAIR OF THE AUTOPULSE.

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHECK, THE AUTOPULSE PLATFORM STOPPED PERFORMING COMPRESSIONS AFTER APPROXIMATELY 20 SECONDS AND DISPLAYED A USER ADVISORY (UA) 27 (ENCODER FAULT (>3000 RPM)) MESSAGE. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517051 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1