BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® PLATFORM RESUSCITATION

    MDR report key: 8621025 · Received May 17, 2019

    Report

    Report Number
    3010617000-2019-00388
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 22, 2019
    Report Date
    May 17, 2019
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    UDI-DI
    00849111000512
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF AUTOPULSE PLATFORM SYSTEM DISPLAYED UA45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) WAS CONFIRMED BY FUNCTIONAL TEST AND ARCHIVE DATA. THE MOST PROBABLE ROOT CAUSE WAS DUE TO A DAMAGE ENCODER GEARBOX WHICH WAS REPLACED TO CORRECT THE ISSUE. UPON VISUAL INSPECTION, THE AUTOPULSE PLATFORM PASSED VISUAL INSPECTION NO VISIBLE DAMAGES WERE OBSERVED. DURING FUNCTIONAL TEST, THE AUTOPULSE FAILED FUNCTIONAL TESTING, SHOWING INTERMITTENT AU45 ERROR MESSAGE DURING EVALUATION DUE TO A DAMAGE ENCODER GEARBOX. UNRELATED TO THE CUSTOMER REPORTED COMPLAINT, THE AUTOPULSE PLATFORM WAS ALSO FOUND WITH A DEBURRING STICKY CLUTCH PLATE. THE LOAD CELL 2 (REGISTERED HIGH ON THE MONITOR) WAS REPLACED TO CORRECT THE ISSUE. A REVIEW OF THE AUTOPULSE'S ARCHIVE DATA WAS PERFORMED AND IT SHOWED MULTIPLE UA45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART), UA18 (MAX TAKE-UP REVOLUTION EXCEEDED) , UA20 (POSITION OUT OF RANGE) AND UA24 (TIMEOUT MOVING TO "HOME" POSITION) ERROR MESSAGES OCCURRED ON THE REPORTED EVENT DATE (B)(6) 2019, CONFIRMING THE REPORTED COMPLAINT. UA45 (DRIVE SHAFT NOT AT HOME POSITION) AND UA18 (MAXIMUM TAKE-UP DEPTH EXCEEDED) ARE COMMON ERRORS THAT OCCUR WHEN THE DEVICE IS POWERED UP FOR SHIFT CHECKS. THEY ARE MOSTLY DUE TO A LIFEBAND BEING STORED ON THE DEVICE WHEN IT IS NOT IN USE. USER ADVISORY IS A CLEARABLE ERROR MESSAGE AND IS DESIGNED INTO THE PLATFORM TO ALERT THE OPERATOR THAT AUTOPULSE HAS DETECTED ONE OF SEVERAL CONDITIONS. IT IS LIKELY THAT THE USER HAS CLEARED THE UA45 (SHAFT NOT AT "HOME" POSITION OCCURRED. THE LIFEBAND STRAPS WERE NOT PULLED COMPLETELY OUT PRIOR TO TURNING THE DEVICE ON.) BEFORE RETURNING THE PLATFORM FOR EVALUATION. THE AUTOPULSE USER GUIDE INSTRUCTS TO CLEAR UA45, THE OPERATOR NEEDS TO PULL UP THE LIFEBAND UNTIL THE CHEST BANDS ARE FULLY EXTENDED. THIS ACTION WILL MOVE THE DRIVESHAFT TO ITS HOME POSITION. THE USER ADVISORY WILL PERSIST UNTIL THE DRIVESHAFT IS RETURNED TO ITS HOME POSITION. USER ADVISORY 18 IS AN INDICATION THAT 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. THE RECOMMENDED ACTIONS TO TAKE FOR THIS TYPE OF USER ADVISORY ARE: PULL UP COMPLETELY ON THE LIFEBAND, ENSURE THAT THE PATIENT AND THE BAND ARE PROPERLY ALIGNED, AND PRESS RESTART. IF THE USER ADVISORY DOES NOT CLEAR, THE PATIENT MAY BE TOO SMALL. IN THIS CASE, REVERT TO MANUAL CPR. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR AUTOPULSE WITH SERIAL NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING MORNING CHECKS, THE AUTOPULSE PLATFORM SYSTEM DISPLAYED UA45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART), TECHNICAL SUPPORT WAS UNABLE TO ASSIST THE CUSTOMER TO CLEAR THE ERROR MESSAGE. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414413 AUTOPULSE® PLATFORM RESUSCITATION CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100 00849111000512

    Patients

    Seq Age Sex Outcome Treatment
    1