BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 1912446 · Received November 4, 2010

    Report

    Report Number
    8010042-2010-00233
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Report Date
    October 10, 2010
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K041223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE VENTILATOR FAILED THE INTERNAL LEAKAGE TEST AND THE PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1