BEUDAMED
    FDA Adverse Event Other Summary report: N

    BEAR

    MDR report key: 1298442 · Received January 27, 2009

    Report

    Report Number
    2021710-2009-00002
    Event Type
    Other
    Date Received
    January 27, 2009
    Date of Event
    January 5, 2009
    Report Date
    January 27, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION THEY RECEIVED FROM THE USER FACILITY. CARDINAL HEALTH ISSUED A RETURNED GOODS AUTHORIZATION (RGA) NUMBER TO THE USER FACILITY FOR THE RETURN OF THE DEVICE FOR EVALUATION. AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN RECEIVED INTO THE MANUFACTURING PLANT FOR EVALUATION. ONCE THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS COMPLETE, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS REPORTED TO CARDINAL HEALTH BY THE FOREIGN DISTRIBUTOR (CARDINAL HEALTH HONG KONG LTD.) VIA AN E-MAIL, BASED ON INFORMATION THEY RECEIVED FROM THE USER FACILITY. "ONE BEAR1000 FIRED DURING VENTILATION TODAY. FORTUITOUSLY, PATIENT WAS FINE AND NOBODY WAS INJURED AND ONLY VENTILATOR WAS DAMAGED COMPLETELY. ITS S/N CANNOT READ FROM MACHINE, AND I ASKED THEM TO FIND OUT RUNNING HOURS-AROUND 11500 HOURS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAR 73CBK VENTILATOR, CONTINUOUS (RESPIRATOR) CBK CARDINAL HEALTH 207, INC. BEAR 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK