BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGMA SPECTRUM

    MDR report key: 953521 · Received July 11, 2006

    Report

    Report Number
    1314492-2006-00004
    Event Type
    Death
    Date Received
    July 11, 2006
    Date of Event
    June 4, 2006
    Report Date
    June 12, 2006
    Manufacturer
    SIGMA INT'L
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED AND EXAMINED AT SIGMA 7/5/06. THE PLUG IN POWER SUPPLY DISPLAYED NO GREEN LED WHEN PLUGGED IN INDICATING NO POWER OUT. BROKEN TRACES CONSISTENT WITH TRAUMA TO THE ASSEMBLY AS A RESULT OF DROPPING WERE IDENTIFIED. WITH NO INDICATION OF POWER (GREEN LED LIT) THIS PUMP SHOULD NOT HAVE BEEN IN SERVICE.

    Description of Event or Problem · 1

    SIGMA SPECTRUM PUMP RETRIEVED FROM HOLDING AREA TO REPLACE PUMP ON PT WITH BATTERY DEPLETION. THIS PUMP WAS PLUGGED INTO THE WALL OUTLET IN THE HOLDING AREA. IT WOULD NOT TURN ON EVEN WHEN PLUGGED IN. CLINICAL ENGINEERS, RM NURSING EVALUATED THE PUMP 6/5/06. THIS WAS REPEATED WITH CEO OF SIGMA AND LOCAL SIGMA REP ON 6/6/06. THE PUMP WOULD NOT TURN ON. UNABLE TO DETERMINE BATTERY CAPACITY. THE STRAIN RELIEF BRACKET INTACT. ONLY ONE SCREW. THE GREEN LED LIGHT ON THE TRANSFORMER (PLUG) IS NOT ON. UNABLE TO GET A READING FROM THE BATTERY CAPACITY. ALL FINDINGS REPORTED TO SIGMA ON 6/6/06.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA SPECTRUM INFUSION PUMP FRN SIGMA INT'L SPECTRUM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death