BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3933374 · Received July 14, 2014

    Report

    Report Number
    3003793491-2014-00339
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    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

    PRODUCT IN COMPLAINT WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2014 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION IDENTIFIED THAT THE TOP COVER WAS CRACKED NEAR THE ON/OFF BUTTON AND THE BATTERY LOCK PIN WAS BENT. FROM THE CONDITION OF THE RETURNED PLATFORM, THE DAMAGES APPEAR TO BE NORMAL WEAR AND TEAR. DURING FUNCTIONAL TESTING, THE PLATFORM EXHIBITED USER ADVISORY 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) FAULTS CONSISTENTLY. FURTHER INSPECTION FOUND THAT THE CAUSE WAS A SINGLE POINT LOAD CELL THAT WAS NOT FUNCTIONING PROPERLY. THE LOAD CELL WAS REPLACED TO REMEDY THE COMPLAINT. UNRELATED TO THE REPORTED COMPLAINT, THE PLATFORM'S DRIVESHAFT WAS ALSO FOUND TO BE DIFFICULT TO ROTATE. FURTHER INSPECTION IDENTIFIED THE CAUSE TO BE THAT THE CLUTCH PLATE WAS DAMAGED. THE CLUTCH PLATE WAS REPLACED AND THE COMPARTMENT WAS CLEANED TO REMEDY THIS ISSUE. REVIEW OF THE ARCHIVE DATA CONFIRMED THAT USER ADVISORY (UA) 7 FAULT HAD OCCURRED ON MULTIPLE DATES, INCLUDING THE REPORTED EVENT DATE OF (B)(6) 2014. BASED ON THE INVESTIGATION, THE PARTS IDENTIFIED FOR REPLACEMENT WERE THE SINGLE POINT LOAD CELL, TOP COVER, BATTERY LOCK PIN, LOAD PLATE COVER, AND CLUTCH PLATE. IN SUMMARY, THE REPORTED COMPLAINT OF A UA 7 FAULT OCCURRING WAS CONFIRMED BASED ON FUNCTIONAL EVALUATION AS WELL AS THROUGH ARCHIVE REVIEW. THE UA 7 FAULT WAS FOUND TO BE DUE TO A SINGLE POINT LOAD CELL THAT WAS NOT FUNCTIONING PROPERLY. DURING FUNCTIONAL TESTING, THE DRIVESHAFT WAS ALSO FOUND TO BE DIFFICULT TO ROTATE, WHICH WAS CAUSED BY THE CLUTCH PLATE BEING DAMAGED. FOLLOWING SERVICE, INCLUDING REPLACEMENT OF THE DAMAGED PARTS, THE DEVICE PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE AUTOPULSE® PLATFORM DISPLAYED A USER ADVISORY (UA) 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE UPON POWER UP. THE FAULT WAS UNABLE TO BE CLEARED AFTER BEING USED ON A PATIENT, THEREFORE THE CREW REVERTED TO MANUAL CPR (EXACT LENGTH OF TIME IS UNKNOWN). INFORMATION REGARDING OUTCOME OF THE PATIENT IS UNKNOWN, HOWEVER NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409190 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 MANUAL CPR