BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEAR

    MDR report key: 167463 · Received May 14, 1998

    Report

    Report Number
    2022747-1998-00133
    Event Type
    Injury
    Date Received
    May 14, 1998
    Report Date
    May 14, 1998
    Manufacturer
    BEAR MEDICAL SYSTEMS
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LAB TESTING: UNIT PLACED IN ENVIRONMENTAL CHAMBER AND OPERATED AT 40 C. UNIT WENT "VENT INOP" AFTER SEVERAL HOURS. APPEARS THAT THE COMPRESSOR MOTOR AND OR THE STARTING CAP ARE BAD. UNIT SENT TO SERVICE DEPARTMENT TO HAVE FAILED COMPONENTS REPLACED AND RETEST UNIT PER LATEST MMP'S AND QCI'S.

    Description of Event or Problem · 1

    REPORT FROM HOSPITAL THAT VENTILATOR WAS CHECKED AND FUNCTIONED CORRECTLY ON A TEST LUNG BUT FAILED TO VENTILATE WHEN ATTACHED TO A PT. HOSPITAL STATED THAT PT DETERIORATED AND REQUIRED RESUSCITATION. AT THIS TIME THE HOSPITAL HAD NOT DETERMINED THAT ANY MALFUNCTION HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAR VOLUME VENTILATOR CBK BEAR MEDICAL SYSTEMS BEAR 2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention