BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I C20

    MDR report key: 7454491 · Received April 24, 2018

    Report

    Report Number
    8010042-2018-00200
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Report Date
    May 17, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANESTHESIA WORKSTATION FAILED THE LEAKAGE TEST DURING SYSTEM CHECK OUT. THERE WAS NO PATIENT CONNECTED TO THE DEVICE DURING THE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE ENGINEER INVESTIGATED THE ANESTHESIA WORKSTATION AT THE HOSPITAL AND CONCLUDED THAT THE MANUAL/AUTOMATIC VENTILATION VALVE MEMBRANE IN THE PATIENT CASSETTE AND THE ACTUATOR MANUAL/AUTOMATIC VENTILATION VALVE HAD BEEN DAMAGED. THE DAMAGED PARTS WERE REPLACED BUT WERE NOT RETURNED FOR INVESTIGATION. IMAGES OF THE DAMAGED PARTS WERE RECEIVED AND OUR CONCLUSION IS THAT THE DAMAGES WERE CAUSED BY ATTEMPTING TO REMOVE THE PATIENT CASSETTE WHILE THE MANUAL/AUTOMATIC VENTILATION VALVE ACTUATOR WAS IN ITS UPPER POSITION, I.E EXCESSIVE OR INADEQUATE PHYSICAL FORCE HAD BEEN APPLIED TO THE PATIENT CASSETTE. THE SYSTEM CHECK OUT IN THE SUPPLIED LOG FAILED DUE TO THE LEAKAGE CAUSED BY THE DAMAGED PARTS. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298415 FLOW-I C20 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C20

    Patients

    Seq Age Sex Outcome Treatment
    1