BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3111617 · Received May 6, 2013

    Report

    Report Number
    1828100-2013-00425
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. THE SUSPECT OXYGEN SENSOR WAS REPLACED AGAIN WITH A NEW SENSOR. THE NEW SENSOR DOES ALLOW THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) TO CALIBRATE.

    Description of Event or Problem · 1

    UPON RECEIPT OF THE DEVICE, THE USER REPORTED THAT THE REPLACEMENT OF AN OXYGEN (O2) SENSOR WAS AN "OUT OF BOX" FAILURE, AS THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) WOULD NOT CALIBRATE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197592 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP. 801074

    Patients

    Seq Age Sex Outcome Treatment
    1