BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 100 MONITOR

    MDR report key: 2152741 · Received June 24, 2011

    Report

    Report Number
    1828100-2011-01764
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 29, 2011
    Report Date
    June 24, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DTY
    PMA / PMN Number
    K902654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE BATTERY WAS LOW EVEN THOUGH THE UNIT WAS PLUGGED IN. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. THERE WERE NO REPORTED 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 100 MONITOR MONITOR DTY TERUMO CARDIOVASCULAR SYSTEM CORP. 100

    Patients

    Seq Age Sex Outcome Treatment
    1