BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-CAL

    MDR report key: 99012 · Received June 12, 1997

    Report

    Report Number
    2124837-1997-00012
    Event Type
    Malfunction
    Date Received
    June 12, 1997
    Date of Event
    May 14, 1997
    Report Date
    June 10, 1997
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT DURING A CASE, THE BIO-CAL WOULD DISPLAY "WATCHDOG" ALARM. THE BIO-CAL WAS REPLACED WITH A SECOND UNIT TO CONTINUE CASE WITH NO EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-CAL CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER DWJ MEDTRONIC BIO-MEDICUS, INC. 370 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other