BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE CYCLE VENTILATOR

    MDR report key: 503155 · Received December 15, 2003

    Report

    Report Number
    MW1030536
    Event Type
    Malfunction
    Date Received
    December 15, 2003
    Date of Event
    October 26, 2003
    Report Date
    December 9, 2003
    Manufacturer
    MONAGHAN MEDICAL CORP
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT BECAME DISCONNECTED FROM VENT IN MRI. THE MRI COMPATIBLE VENT DOES NOT HAVE A LOW PRESSURE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE CYCLE VENTILATOR VENTILATOR CBK MONAGHAN MEDICAL CORP 225SIMV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA