BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM

    MDR report key: 1870325 · Received September 23, 2010

    Report

    Report Number
    1870325
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 16, 2010
    Report Date
    September 23, 2010
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    BATTERY MALFUNCTIONED. FOUND THAT AC POWER CORD WAS BROKEN & BATTERY LOW. REPLACED AC POWER ADAPTOR & CHARGED BATTERY FOR 24 HOURS. PUMP RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM IV PUMP FRN SIGMA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *