BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRWAY PRESSURE MONITOR

    MDR report key: 34078 · Received May 14, 1996

    Report

    Report Number
    1317346-1996-00001
    Event Type
    Malfunction
    Date Received
    May 14, 1996
    Date of Event
    April 26, 1996
    Report Date
    May 14, 1996
    Manufacturer
    MONAGHAN MEDICAL CORP.
    Product Code
    CAP
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AIRWAY PRESSURE MONITOR WAS REPORTED TO HAVE FAILED TO EXHIBIT LOW PRESSURE ALARM CONDITION WHEN PT CIRCUIT BECOME DISLODGED FROM THE TRACHEAL TUBE. AN ATTENDING THERAPIST RE-CONNECTED BREATHING CIRCUIT WITHOUT ANY FURTHER INCIDENT. DEVICE WAS NOT PROPERLY SET UP PRIOR TO OPERATION. UNIT WAS SUBSEQUENTLY SET UP ACCORDING TO MFR'S SPECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRWAY PRESSURE MONITOR AIRWAY PRESSURE MONITOR CAP MONAGHAN MEDICAL CORP. CM5000SC Q583

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN