BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 2110965 · Received March 25, 2011

    Report

    Report Number
    8010042-2011-00051
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    January 21, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE EXEMPTION #: (B)(4).

    Description of Event or Problem · 1

    THE VENTILATOR FAILED THE INTERNAL LEAKAGE TEST DURING PRE-USE CHECK. HIGH PRESSURE ALARM WAS GENERATED DURING VENTILATION. (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