BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 3943770 · Received April 30, 2014

    Report

    Report Number
    1828100-2014-00364
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 16, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE LABORATORY EVAL, THE TECHNICIAN OBSERVED THAT THE PINK WIRE FROM THE OUTPUT OF THE LIQUID CRYSTAL DISPLAY (LCD) DRIVER PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) HAS TWO NICKS IN IT. THIS MAY CAUSE DISPLAY ISSUES IF IT IS SHORTED TO CHASSIS GROUND OR OTHER POINTS OF GROUND AS THESE LINES HAVE APPROX 330 VOLTS A/C ON THEM GOING TO THE DISPLAY. THE BLOOD PARAMETER MONITOR (BPM) PASSED STARTUP SELF-DIAGNOSTICS WITH NO ERRORS OBSERVED, AND NO LINE FROM TOP TO BOTTOM OBSERVED PER THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    THE SUBSIDIARY SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SUBSIDIARY'S MFG ENGINEERING CENTER (MEC), THE BLOOD PARAMETER MONITOR (BPM) DISPLAY FAILED. ONE LINE WAS DISPLAYED FROM TOP TO BOTTOM ON THE SCREEN, BUT WAS STILL READABLE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258353 TERUMO CDI 500 BLOOD PARAMETER MONITOR CDI 500 DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. 500AVHCT

    Patients

    Seq Age Sex Outcome Treatment
    1