BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BABYLOG INFANT PRESSURE VENTILATOR

    MDR report key: 61559 · Received January 10, 1997

    Report

    Report Number
    MW1010545
    Event Type
    Injury
    Date Received
    January 10, 1997
    Date of Event
    December 23, 1996
    Report Date
    December 29, 1996
    Manufacturer
    DRAGER, INC.
    Product Code
    LSZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    FACE OF VENTILATOR WAS VERY HOT FROM TRIGGER LEVER ACROSS TO ALARM SILENCE. THE TEMP ON THE FACE OF THE VENTILATOR WAS MEASURED AT 280 DEGREES F. NO ALARMS WERE SOUNDED AND NO OTHER MALFUNCTION WAS NOTED. NURSE CARING FOR THE PT SUSTAINED A BURN TO HER HAND. THE PT DID NOT SUSTAIN INJURY. THE VENTILATOR WAS REMOVED FROM PT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BABYLOG INFANT PRESSURE VENTILATOR HIGH FREQUENCY OSCILLATORY VENTILATOR LSZ DRAGER, INC. BABYLOG 8000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DAY Required Intervention