BEUDAMED
    FDA Adverse Event Death Summary report: N

    FILTA THERM

    MDR report key: 74832 · Received March 5, 1997

    Report

    Report Number
    1319447-1997-90001
    Event Type
    Death
    Date Received
    March 5, 1997
    Date of Event
    February 2, 1997
    Report Date
    February 6, 1997
    Manufacturer
    INTERSURGICAL, INC.
    Product Code
    CAH
    Removal / Correction Number
    00297
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    UPON ARRIVAL FOR ROUTINE VENTILATOR CHECK AND TREATMENT, FOUND PT DISCONNECTED FROM THE VENT. NO AUDIBLE OR VISUAL ALARMS. VENTILATOR FUNCTIONAL CHECK AFTER REMOVAL FROM PT, LOW PRESSURE ALARM SET TO 12CM H20. WITH VENTILATOR CYCLING, RESISTANCE IN THE CIRCUIT EXCEEDED 10-12CM H20. WITH HEAT MOISTURE EXCHANGE FILTER REMOVED FROM THE CIRCUIT, THE LOW PRESSURE ALARM SOUNDED. CONCLUDE THAT RESISTANCE IN HME EXCEEDED THE LOW PRESSURE ALARM SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTA THERM HUMIDIFIERS, HEAT/MOISTURE EXCHANGE CAH INTERSURGICAL, INC. FILTA-THERM *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death