BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3913615 · Received July 3, 2014

    Report

    Report Number
    3003793491-2014-00320
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL CIRCULATION 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.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND FOUND THAT THE FRONT ENCLOSURE WAS DAMAGED. FROM THE CONDITION OF THE UNIT, IT APPEARS THE DAMAGE WAS DUE TO WEAR AND TEAR. THE REPORTED USER ADVISORY 7 FAULT (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) WAS OBSERVED DURING POWER UP OF THE PLATFORM. FURTHER INSPECTION IDENTIFIED THAT THE UA 7 WAS CAUSED BY A LOAD CELL NOT FUNCTIONING PROPERLY. NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE OBSERVED UA 7. A REVIEW OF THE ARCHIVE WAS PERFORMED AND IT WAS CONFIRMED THAT THE REPORTED UA 7 OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. A USER ADVISORY 12 (LIFEBAND NOT PRESENT) ALSO OCCURRED ON THE REPORTED EVENT DATE AND WAS LIKELY DUE TO THE LIFEBAND CLIP NOT BEING INSERTED CORRECTLY BY THE CUSTOMER. BASED ON THE INVESTIGATION, THE PARTS IDENTIFIED FOR REPLACEMENT WERE THE FRONT ENCLOSURE AND THE SINGLE POINT LOAD CELL. IN SUMMARY, THE REPORTED COMPLAINT WAS CONFIRMED DURING FUNCTIONAL INSPECTION AS WELL AS ARCHIVE REVIEW AND WAS FOUND TO BE DUE TO A SINGLE POINT LOAD CELL NOT FUNCTIONING PROPERLY. FOLLOWING SERVICE, INCLUDING REPLACEMENT OF THE DAMAGED PARTS, THE DEVICE PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING PATIENT USE, THE AUTOPULSE® PLATFORM DISPLAYED A USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE. THE USER REVERTED TO MANUAL CPR (EXACT LENGTH OF TIME IS UNKNOWN). IT IS UNKNOWN IF THE PATIENT SURVIVED OR EVER ACHIEVED ROSC (RETURN OF SPONTANEOUS CIRCULATION). NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391075 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 MANUAL CPR