BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAR 1000

    MDR report key: 202112 · Received December 15, 1998

    Report

    Report Number
    MW1015234
    Event Type
    Malfunction
    Date Received
    December 15, 1998
    Date of Event
    November 6, 1998
    Report Date
    December 2, 1998
    Manufacturer
    BEAR MEDICAL SYSTEMS, INC. VENTILATION PRODUCT DIV.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PT INTUBATED IN INTENSIVE CARE UNIT DUE TO DETERIORATING MEDICAL CONDITION. APPROX ONE HR AFTER INTUBATING, VENTILATOR WENT INOPERATIVE IN "FAIL TO CYCLE" MODE. STAFF PRESENT AT TIME, PT BAGGED; SUBSEQUENTLY CODED AND EXPIRED. THERE HAVE BEEN MULTIPLE PRIOR CASES OF FAIL TO CYCLE EVENTS AT THIS INSTITUTION WITH "E12" AND "E31" ERROR CODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAR 1000 ADULT VOLUME VENTILATOR CBK BEAR MEDICAL SYSTEMS, INC. VENTILATION PRODUCT DIV. 1000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other