BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2861195 · Received November 2, 2012

    Report

    Report Number
    1314492-2012-00389
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Report Date
    October 3, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION. IT WAS CONFIRMED THAT THE AUDIO FUNCTION WAS NOT PRESENT. FURTHER EVALUATION IDENTIFIED THAT THE ABSENCE OF AUDIO WAS DUE TO FAILED 1 WATT SPEAKER. ALL DETECTION CAPABILITIES AND VISUAL FUNCTIONS PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP DID NOT HAVE AUDIO FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1