BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2820457 · Received October 4, 2012

    Report

    Report Number
    1314492-2012-00344
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    May 23, 2012
    Manufacturer
    SIGMA INTL.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION. IT WAS OBSERVED THAT WHEN ANY KEY IS SELECTED, AN ADD'L RESPONSE OF THE SELECTED KEY IS DISPLAYED, CAUSED BY A FAILED KEYPAD. THIS DOES NOT ALLOW THE USER TO START AN INFUSION. SIGMA'S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE #8 KEY ON A PUMP KEYPAD IS INOPERABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM INFUSION PUMP INFUSION PUMP FRN SIGMA INTL. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1