BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM

    MDR report key: 2493855 · Received March 12, 2012

    Report

    Report Number
    2493855
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    March 23, 2012
    Report Date
    March 12, 2012
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    PUMP BEEPING. WHEN TOUCHED BY PARAMEDIC AND NURSE IT SHOCKED THEM BOTH. THE SCREEN TURNED OFF AND STATED IT SHOULD BE "SHUT OFF AGAIN THEN RESTARTED". PUMP WOULD NOT RESTART. THEN IT STATED IT NEEDED SERVICE AND CONTINUED BEEPING. HAD TO TURN OFF HEPARIN INFUSION FOR MORE THAN 15 MINUTES AND SWITCH OUT PUMP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR