BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2960969 · Received January 30, 2013

    Report

    Report Number
    1828100-2013-00119
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS 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. PER EVALUATION REPORT: THE SERVICE REPAIR TECHNICIAN (SRT) CONNECTED THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) TO A SYSTEM ONE SIMULATOR AND CENTRAL CONTROL MONITOR (CCM), ATTACHED OXYGEN AND AIR AT 50 PSI, ENTERED THE PERFUSION SCREEN ON THE CCM AND WAITED THE FIFTEEN MINUTE OXYGEN (02) SENSOR WARM-UP PERIOD. CALIBRATION OF THE EPGS WERE INITIATED AND PASSED. USING THE CCM CONTROL, THE FSR WAS ABLE TO MOVE THE FIO2 KNOB THROUGH IT'S ENTIRE RANGE. THE SRT DOWNLOADED THE LOGS FOR FURTHER EVALUATION. THERE WAS NO INDICATION ON THE EPGS WHEN THE LAST MAINTENANCE WAS PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPAIR TECHNICIAN (SRT) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE ELECTRONIC PATIENT GAS SYSTEM (EPGS) FAILED THE AUTOMATED TEST EQUIPMENT (ATE) TESTING. THE UNIT FAILED TEST 49, EXTERNAL 02% WITH SETPOINT AT 90% 86.7; (LOW _LIMIT = 87.4, HIGH_LIMIT = 93.4). UNIT IS BELOW THE LOW LIMIT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40094 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801188

    Patients

    Seq Age Sex Outcome Treatment
    1