BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAR CUB 750

    MDR report key: 70418 · Received February 20, 1997

    Report

    Report Number
    2022747-1997-00023
    Event Type
    Malfunction
    Date Received
    February 20, 1997
    Date of Event
    January 20, 1997
    Report Date
    February 20, 1997
    Manufacturer
    ALLIED HEALTHCRE PRODUCTS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT THE VENTILATOR ALARM FAIL TO CYCLE, WITH THE SETTINGS OR RATE 16, SIMV, 24% OXYGEN, PIP 20, AND PEEP + 4 CMH2O. THE INFANT WAS PLACED ON THE VENTILATOR AT 07:15 AM AND THE EVENT OCCURRED 3 HOURS LATER. THE HOSP STATED THAT THE PEEP WAS STILL ON THE VENTILATOR AFTER THE FAIL TO CYCLE AND BELIEVED THAT THE INFANT WAS BREATHING SPONTANEOUSLY. THE HOSP STATED THAT THERE WAS NO INCIDENT REPORT WRITTEN. NO DECELERATION OR BRADYCARDIA OR DESATURATION OF OXYGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAR CUB 750 INFANT VENTILATOR CBK ALLIED HEALTHCRE PRODUCTS, INC. 750 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention