BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 2110928 · Received March 18, 2011

    Report

    Report Number
    8010042-2011-00041
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS GIVING MULTIPLE ALARMS DURING PT VENTILATION AND IT WAS SUBSEQUENTLY TAKEN OUT OF SERVICE. THE VENTILATOR FAILED THE INTERNAL LEAKAGE, PRESSURE TRANSDUCER AND FLOW TRANSDUCER TESTS DURING PRE-USE CHECK PERFORMED AFTER THE EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1