BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PERFUSION SYSTEM 8000

    MDR report key: 2770301 · Received October 1, 2012

    Report

    Report Number
    1828100-2012-01325
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 6, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K915183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY BIOMEDICAL ENGINEER REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE TEMPERATURE DISPLAY READ "999" WITH NO PROBE INSERTED. IT SHOULD HAVE READ ALL DASHES ("---"). SINCE THE EVENT OCCURRED DURING THE PREVENTATIVE MAINTENANCE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO PERFUSION SYSTEM 8000 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 16414

    Patients

    Seq Age Sex Outcome Treatment
    1