BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4706433 · Received April 16, 2015

    Report

    Report Number
    1828100-2015-00287
    Event Type
    Malfunction
    Date Received
    April 16, 2015
    Report Date
    March 23, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE FIELD SERVICE REPRESENTATIVE (FSR), THE O2 SENSORS ARE NOT REPLACED BY THE CUSTOMER'S THIRD PARTY WHEN THEY PERFORM PREVENTIVE MAINTENANCE (PM) IN THIS HOSPITAL. THE FSR VERIFIED THE COMPLAINT. THE LAST O2 SENSOR REPLACEMENT IS UNK. THE FSR REPLACED THE O2 SENSOR, RESET O2 HOURS AND CHECKED OPERATION. THE UNIT OPERATED TO MFR SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) THAT THE ELECTRONIC PT GAS SYSTEM (EPGS) WAS FAILING CALIBRATION. THE BIOMED OBSERVED AN ERROR CODE OF: 23 2761, WHICH MEANT THE OXYGEN (O2) SENSOR MEASURED 2.761 MILLIVOLTS (MV) WHICH IS OUT OF RANGE. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254449 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (EPGS) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801188

    Patients

    Seq Age Sex Outcome Treatment
    1