BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4563873 · Received February 27, 2015

    Report

    Report Number
    1828100-2015-00126
    Event Type
    Malfunction
    Date Received
    February 27, 2015
    Date of Event
    February 3, 2015
    Report Date
    February 4, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE USER MEDICAL FACILITY, THE TOUCH PANEL OF THE QUANTUM CONTROL UNIT (QCU) FAILED. BY SLIDING THE CURSOR FROM THE LEFT BELOW TO UPPER LEFT, THE CURSOR SHIFTS FROM THE POINT TOUCHED BY FINGER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140501 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802100

    Patients

    Seq Age Sex Outcome Treatment
    1