BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION MODEL 100

    MDR report key: 4517428 · Received February 13, 2015

    Report

    Report Number
    3010617000-2015-00094
    Event Type
    Malfunction
    Date Received
    February 13, 2015
    Date of Event
    January 19, 2015
    Report Date
    January 19, 2015
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON 01/30/2015 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS FOR THE RETURNED PLATFORM AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED AND FOUND NO DAMAGES TO THE PLATFORM. THE PLATFORM WAS UNABLE TO UNDERGO INITIAL FUNCTIONAL TESTING AS IT EXHIBITED A USER ADVISORY (UA) 16 (TIMEOUT MOVING TO TAKE-UP POSITION) UPON POWER ON. A REVIEW OF THE PLATFORM'S ARCHIVE DATA WAS PERFORMED AND FOUND THAT MULTIPLE UA 2 (COMPRESSION TRACKING ERROR), UA 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE), UA 12 (LIFEBAND NOT PRESENT) AND UA 16 (TIMEOUT MOVING TO TAKE-UP POSITION) MESSAGES OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2015. PER THE AUTOPULSE TECHNICAL SERVICE GUIDE (P/N 11377-006), UA 2 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. PER THE AUTOPULSE TECHNICAL SERVICE GUIDE (P/N 11377-006), UA 7 IS EXHIBITED WHEN THE PLATFORM DETECTS THAT THE PATIENT IS NOT PROPERLY CENTERED. PER THE AUTOPULSE® MAINTENANCE GUIDE (P/N 11653-001), UA12 OCCURS WHEN THE AUTOPULSE DETECTS THAT THE LIFEBAND IS NOT PROPERLY INSTALLED. THE AUTOPULSE IS DESIGNED TO EXHIBIT USER ADVISORIES TO PREVENT PATIENT INJURY. BASED ON THE INVESTIGATION, NO PARTS NEEDED TO BE REPLACED TO REMEDY THE CUSTOMER'S REPORTED COMPLAINT OF THE PLATFORM NOT PROCEEDING PAST THE "INITIALIZATION" STAGE; HOWEVER, THE DRIVETRAIN MOTOR BRAKE WAS CLEANED TO REMEDY THE CUSTOMER'S REPORTED COMPLAINT. THE PLATFORM THEN UNDERWENT AND PASSED ALL FINAL FUNCTIONAL TESTING. IN SUMMARY, THE CUSTOMER'S REPORTED COMPLAINT OF THE PLATFORM NOT PROCEEDING PAST THE "INITIALIZATION" STAGE WAS CONFIRMED THROUGH INITIAL FUNCTIONAL TESTING, AND ALSO VISUALLY, ONCE THE PLATFORM WAS OPENED UP. THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS DETERMINED TO HAVE BEEN DUE TO THE DRIVETRAIN MOTOR BRAKE SEIZING AND NOT OPENING. THE DRIVETRAIN MOTOR BRAKE WAS CLEANED, REMEDYING THE CUSTOMER'S REPORTED COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT CARE, THE AUTOPULSE PLATFORM WAS POWERED ON AND DISPLAYED THE "INITIALIZING" MESSAGE; HOWEVER, IT DID NOT PROCEED PASS ITS SELF-TESTS AND DID NOT START COMPRESSIONS. CUSTOMER USED MULTIPLE FULLY CHARGED AUTOPULSE LI-ION BATTERIES BUT THE PLATFORM DID NOT PROVIDE ANY COMPRESSIONS. THE CREW REVERTED TO MANUAL CPR (EXACT LENGTH OF TIME WAS NOT PROVIDED). NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108624 AUTOPULSE® RESUSCITATION MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 MANUAL CPR