BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 100 MONITOR

    MDR report key: 1940206 · Received December 23, 2010

    Report

    Report Number
    1828100-2010-02732
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 23, 2010
    Manufacturer
    TERUMO CARDIVASCULAR SYSTEMS CORP.
    Product Code
    DTY
    PMA / PMN Number
    K902654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE USER REPORTED THE MONITOR WOULD NOT HOLD A CHARGE. 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 HEMATOCRIT SATURATION MONITOR DTY TERUMO CARDIVASCULAR SYSTEMS CORP. 100

    Patients

    Seq Age Sex Outcome Treatment
    1