BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2925283 · Received January 17, 2013

    Report

    Report Number
    1828100-2013-00030
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 22, 2012
    Report Date
    December 22, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING FIELD SERVICE INSTALLATION OF THE DEVICE, THE ULTRASONIC LEVEL SENSOR WAS NOT RESPONDING. SINCE THE EVENT OCCURRED DURING FIELD SERVICE INSTALLATION, THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25629 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 195274

    Patients

    Seq Age Sex Outcome Treatment
    1