BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-CAL

    MDR report key: 274329 · Received April 14, 2000

    Report

    Report Number
    2124837-2000-00006
    Event Type
    Malfunction
    Date Received
    April 14, 2000
    Date of Event
    March 15, 2000
    Report Date
    April 14, 2000
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Product Code
    DWJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING THE PROCEDURE, THE UNIT WAS ALARMING ON "WATER PROBE FAULT". THE BIO-CAL WAS CHANGED OUT WITHOUT ANY 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 AK0844

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other