BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 2934428 · Received January 11, 2013

    Report

    Report Number
    1828100-2013-00011
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS CONFIRMED BY THE SERVICE REPAIR TECH (SRT). THE SRT WILL REPLACE THE POWER SUPPLY, TEST TO MFR'S SPECIFICATIONS, AND RETURN TO CLINICAL USE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    THE SERVICE REPAIR TECH (SRT) REPORTED THAT DURING SAFETY TESTING OF THE DEVICE AT THE SERVICE CENTER, FAILURE OF THE HIGH POTENTIAL TEST OCCURRED. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18520 TERUMO CDI 500 BLOOD PARAMETER MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. 500AHCT

    Patients

    Seq Age Sex Outcome Treatment
    1