BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIRWAY PRESSURE MONITOR

    MDR report key: 701003 · Received April 18, 2006

    Report

    Report Number
    2518422-2006-00021
    Event Type
    Death
    Date Received
    April 18, 2006
    Date of Event
    February 24, 2006
    Report Date
    March 20, 2006
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CAP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE CAREGIVER VIA A MED WATCH REPORT THAT A VENTILLATOR-DEPENDENT PATIENT ALLEGEDLY BECAME DISCONNECTED FROM THE VENTILLATOR.NEITHER THE VENTILLATOR NOR THE SUBJECT DEVICE WERE REPORTED TO HAVE ALARMED.ACCORDING TO THE CAREGIVER,THE PATIENT WAS FOUND 30 MINUTES LATER AND HAD EXPIRED.AT THIS TIME,IT IS UNK IF AN AUTOSPY WAS PERFORMED. BOTH DEVICES WERE REPORTEDLY BEING USEDC IN CONJUCTION WITH A HEAT MOISTURE EXCHANGER (HME) FOR HUMIDFICAION.THE VENTILLATOR'S SETTINGS WERE REPORTED AS FOLLOWS;MODE: ASSIST CONTROL, RATE: 14, TIDAL VOLUME: 330CC, HIGH PRESSURE ALARM: 60CM H2O AND LOW PRESSURE ALARM: 10CM H2O.THE AIRWAY PRESSURE MONITOR AND CIRCUT WERE REPORTED TO HAVE A HIGH PRESSURE SETTING OF 60CM H2O AND A LOW PRESSURE SETTING OF 10 CM H2O.THE VENTILLATOR, AIRWAY PRESSURE MONITOR AND CIRCUT WERE ELEVATED BY THE FACILITY AND IT WAS DETERMINED THAT THE HME HAD BECOME CLOGGED.THE AIRWAY PRESSURE MONITOR WAS REPORTED TO HAVE REGISTERED 24 CM H2O OF BACK PRESSURE WITH THE HME IN LINE WITHOUT BEING CONNECTED TO A PATIENT.BASED ON THE LOW PRESSURE ALARM SETTING OF 10 CM H2O AND CIRCUT PRESSURE OF 24 CM H2O, THE DEVICE WOULD NOT RECOGNIZE A DISCONNECT AS A LOW PRESSURE CONDITION WITH THIS LOW PRESSURE ALARM SETTING.THE PATIENT'S PEAK PRESSURE WAS REPORTED TO BE 37 CM H2O.WHEN THE DEVICE AND CIRCUT WERE TESTED WITH A NEWHME,THE DEVICE WAS REPORTED TO HAVE ALARMED CORRECTLY. MEDWATCH 2518422-2006-00017 WAS PREVIOUSLY FILED ON THE VENTILLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRWAY PRESSURE MONITOR MONITOR, AIRWAY PRESSURE CAP RESPIRONICS, INC. 332259 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death