BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 100 MONITOR

    MDR report key: 1854293 · Received September 30, 2010

    Report

    Report Number
    1828100-2010-01607
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 30, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTY
    PMA / PMN Number
    K902654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    THE USER REPORTED THE BATTERY CASING FELL OFF IN PIECES. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. THE DEVICE WAS USED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO 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 100 MONITOR MONITOR DTY TERUMO CARDIOVASCULAR SYSTEMS CORP. 100

    Patients

    Seq Age Sex Outcome Treatment
    1