BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT SWIVAL ADAPTOR

    MDR report key: 68725 · Received February 11, 1997

    Report

    Report Number
    68725
    Event Type
    Death
    Date Received
    February 11, 1997
    Date of Event
    February 2, 1997
    Report Date
    February 11, 1997
    Manufacturer
    SIMS
    Product Code
    BZA
    Adverse Event
    Yes
    Report Source
    User Facility 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 VENT. NO AUDIBLE ALARMS FROM VENTILATOR. VENTILATOR FUNCTION CHECK DONE AFTER REMOVAL FROM PT. LOW PRESSURE ALARM SET AT 12CM H2O. WITH VENT CYCLING THE CIRCUIT RESISTANCE EXCEEDED 10-12CM H2O. WITH HEAT MOISTURE EXCHANGE FILTER REMOVED THE LOW PRESSURE ALARM SOUNDED. CONCLUDE THAT RESISTANCE IN HME EXCEEDED LOW PRESSURE ALARM SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT SWIVAL ADAPTOR TRACHEOSTOMY ADAPTOR BZA SIMS 525301 *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death