BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2171053 · Received July 1, 2011

    Report

    Report Number
    1828100-2011-01892
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 9, 2012
    Report Date
    July 1, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    UPON RECEIPT OF THE DEVICE, THE USER REPORTED THAT TWO NEW VENOUS TEMPERATURE PROBE CABLES DID NOT WORK (BROKEN). THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 TEMPERATURE PROBE DTQ TERUMO CARDIOVASCULAR SYSTEM CORP. 24710008

    Patients

    Seq Age Sex Outcome Treatment
    1