BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA MODEL SPECTRUM

    MDR report key: 2023953 · Received March 16, 2011

    Report

    Report Number
    1314492-2011-00010
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY EVALUATION INDICATES A LOWER BEARING FAILURE OCCURRED. A FOLLOW-UP REPORT WILL BE SUBMITTED, ONCE A FULL EVALUATION HAS BEEN CONDUCTED BY SIGMA ENGINEERING.

    Description of Event or Problem · 1

    A SPECTRUM PUMP WAS RETURNED FOR REPAIR FOR NOISY OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA MODEL SPECTRUM SPECTRUM INFUSION PUMP FRN SIGMA LLC 35700 751049

    Patients

    Seq Age Sex Outcome Treatment
    1