BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA MODEL SPECTRUM

    MDR report key: 1970313 · Received January 21, 2011

    Report

    Report Number
    1314492-2011-00005
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 21, 2011
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP WILL BE SUBMITTED, ONCE A FULL EVALUATION HAS BEEN CONDUCTED BY SIGMA ENGINEERING.

    Description of Event or Problem · 1

    DURING AN INFUSION, A PATIENT'S SPOUSE ENTERED ROOM AND TOOK OFF COAT. SHE THEN HUGGED PT AND RECEIVED A SHOCK. ONE MINUTE LATER, PUMP ALARMED AND WENT INTO A WHITE SCREEN. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION REQUIRED. BIOMEDICAL ENGINEERING REPORTED THAT THE PUMP APPEARS TO BE FUNCTIONING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA MODEL SPECTRUM SPECTRUM INFUSION PUMP FRN SIGMA LLC 35700 737433

    Patients

    Seq Age Sex Outcome Treatment
    1