BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 101 MONITOR

    MDR report key: 1842504 · Received August 31, 2010

    Report

    Report Number
    1828100-2010-01250
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 31, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTY
    PMA / PMN Number
    K902654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE DEVICE WOULD BOOT UP, BUT THE SOFT KEYS WOULD NOT FUNCTION AS EXPECTED. THE USER REPORTED THE INTERFACE MODULE CABLE WAS REPLACED RENDERING THE DEVICE OPERABLE. THE USER REPORTED THAT THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO A PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CDI 101 MONITOR INTERFACE MODULE DTY TERUMO CARDIOVASCULAR SYSTEMS CORP. 7101

    Patients

    Seq Age Sex Outcome Treatment
    1