BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 101 MONITOR

    MDR report key: 2092527 · Received May 2, 2011

    Report

    Report Number
    1828100-2011-01164
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 2, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTY
    PMA / PMN Number
    K902654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER REPORTED A COMMUNICATION PROBLEM WITH THE INTERFACE MODULE. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED FOR THE PROCEDURE. 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 101 MONITOR INTERFACE MODULE DTY TERUMO CARDIOVASCULAR SYSTEM CORP 7101

    Patients

    Seq Age Sex Outcome Treatment
    1