BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURITAN BENNETT

    MDR report key: 18596 · Received October 25, 1994

    Report

    Report Number
    18596
    Event Type
    Injury
    Date Received
    October 25, 1994
    Date of Event
    October 18, 1994
    Report Date
    October 21, 1994
    Manufacturer
    PURITAN-BENNETT CORP.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PT ON VENTILATOR. AUDIBLE AND VISUAL ALARMS ACTIVATED. WINDOW SHOWED "ERROR CODE-DO NOT USE." VENTILATOR DID NOT RESPOND WITH BACK-UP MODE. PT IMMEDIATELY REMOVED FROM MALFUNCTIONING VENTILATOR, MANUALLY VENTILATED AND THEN PLACED ON A DIFFERENT VENTILATOR. SETTINGS: VT800; A/C 6; PEEP 3+; FIO2 .35; CPAP 3+. ALARM SETTINGS: HIGH PRESSURE 50, LOW PRESSURE 10; LOW PEEP 1; LOW EXH. VT600; LOW EXH. V 4.0; HIGH RR 30; O2 ANALYZER HI 45; WW 25; APNEA TIME 20 SEC.; APNEA VT 800; APNEA RR 8; APNEA FIO2 1.0; APNEA PF 50.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PURITAN BENNETT VOLUME VENTILATOR-7200AE CBK PURITAN-BENNETT CORP. 7200AE

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R