BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 101 MONITOR

    MDR report key: 2052103 · Received March 1, 2011

    Report

    Report Number
    1828100-2011-00462
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 7, 2011
    Report Date
    March 1, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTY
    PMA / PMN Number
    K902654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE MONITOR DID NOT FUNCTION AS EXPECTED. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. THERE WERE NO REPORTED 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 101 MONITOR MONITOR DTY TERUMO CARDIOVASCULAR SYSTEMS CORP. 101

    Patients

    Seq Age Sex Outcome Treatment
    1