BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 1900440 · Received October 28, 2010

    Report

    Report Number
    1828100-2010-01886
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 28, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE FIELD SERVICE REPRESENTATIVE REPORTED THAT WHILE POSITIONING THE SCREEN, THE ARM HOLDING THE CENTRAL CONTROL MONITOR MADE A SQUEAKING NOISE. THE FIELD SERVICE REPRESENTATIVE HAS ORDERED PARTS TO CORRECT THE NOISE ISSUE. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 CENTRAL CONTROL MONITOR DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP 816300

    Patients

    Seq Age Sex Outcome Treatment
    1