BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION MODEL 100

    MDR report key: 4615037 · Received March 18, 2015

    Report

    Report Number
    3010617000-2015-00151
    Event Type
    Malfunction
    Date Received
    March 18, 2015
    Date of Event
    February 26, 2015
    Report Date
    February 26, 2015
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 THAT WAS PERFORMED ON 3/17/15. THE PLATFORM WAS RUN WITH A TEST MANNEQUIN AND NO ANOMALIES OR ERRORS WERE EXHIBITED. A REVIEW OF THE AUTOPULSE ARCHIVE WAS PERFORMED WHICH CONFIRMED THE CUSTOMER'S REPORTED COMPLAINT. THE FOLLOWING USER ADVISORIES (UAS): 2 (COMPRESSION TRACKING ERROR), 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE), 8 (MOTOR CONTROLLER FAULT DETECTED), 18 (MAX TAKE-UP REVOLUTIONS EXCEEDED), 29 (LOSS OF BRAKE CONNECTIVITY) AND 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ALL OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2015. PER AUTOPULSE TECHNICAL SERVICE GUIDE (P/N 11377-006), A UA2 OCCURS 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. PER AUTOPULSE TECHNICAL SERVICE GUIDE (P/N 11377-006), A UA7 IS SHOWN WHEN THE PLATFORM DETECTS THAT THE PATIENT IS NOT PROPERLY CENTERED. PER AUTOPULSE TECHNICAL SERVICE GUIDE (P/N 11377-006), A UA18 PRESENTS 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. UA45 IS MOST COMMONLY EXHIBITED WHEN THE LIFEBAND STRAPS ARE NOT FULLY EXTENDED BEFORE PRESSING START. BASED ON THE INVESTIGATION RESULTS, THE DRIVETRAIN, ENCODER GEARBOX AND PROCESSOR PCA ASSEMBLY WERE ALL REPLACED TO REMEDY THE CUSTOMER'S REPORTED COMPLAINT THAT THE PLATFORM EXHIBITED USER ADVISORIES (UAS) 2, 8, 18 & 29. AFTER THESE PARTS WERE REPLACED, FINAL FUNCTIONAL TESTING WAS PERFORMED FOR APPROXIMATELY 22 MINUTES AND NO PROBLEMS WERE FOUND. THE CUSTOMER'S REPORTED COMPLAINT WAS CONFIRMED THROUGH REVIEW OF THE PLATFORM ARCHIVE. A ROOT CAUSE OF THE UA2 WAS DETERMINED TO HAVE BEEN CAUSED BY PATIENT MOVEMENT. THE UA8 IS ATTRIBUTED TO THE DEFECTIVE ENCODER GEARBOX ASSEMBLY. THE UA18 WAS DETERMINED TO HAVE BEEN CAUSED BY NO LOAD CHANGE ON THE PLATFORM. UA29 OCCURRED AS A RESULT OF THE BRAKE NOT PROPERLY ENGAGING. THE DRIVETRAIN AND PROCESSOR PCA WERE BOTH REPLACED, WHICH REMEDIED THE UA 29. THE PLATFORM PASSED ALL FINAL TESTING.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON 03/16/2015 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE, THE AUTOPULSE PLATFORM DISPLAYED THE FOLLOWING USER ADVISORY (UA) 2 (COMPRESSION TRACKING ERROR), 8 (MOTOR CONTROLLER FAULT DETECTED), 18 (MAX TAKE-UP REVOLUTIONS EXCEEDED) AND 29 (LOSS OF BRAKE CONNECTIVITY) MESSAGES. CUSTOMER REVERTED TO MANUAL CPR (EXACT LENGTH OF TIME WAS NOT PROVIDED). NO SPECIFIC PATIENT INFORMATION WAS PROVIDED, HOWEVER NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185178 AUTOPULSE® RESUSCITATION MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1