BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 2201229 · Received July 29, 2011

    Report

    Report Number
    1828100-2011-02330
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 29, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT A DATE AND TIME ERROR MESSAGE OCCURRED WHEN UNIT IS POWERED ON. THE DATE AND TIME INFO IS INCORRECT (1999) AND WHEN THE USER RESETS THE CORRECT DATE AND TIME, IT REVERTS BACK TO THE INCORRECT SETTING AS IF BY DEFAULT. THE USER WAS ABLE TO USE THE MONITOR AND REPORT THAT THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CDI 500 BLOOD PARAMETER MONITOR ON LINE BLOOD GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. 500AHCT

    Patients

    Seq Age Sex Outcome Treatment
    1