BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGMA

    MDR report key: 190098 · Received September 16, 1998

    Report

    Report Number
    1314492-1998-00009
    Event Type
    Other
    Date Received
    September 16, 1998
    Date of Event
    July 10, 1998
    Report Date
    July 13, 1998
    Manufacturer
    SIGMA INTL.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SIGMA 6000+ PUMP DISPLAY READS "BAD RAM" WHEN TURNED ON FROM DC CURRENT. AFFECTED 4 PUMPS IN 3 WEEKS. MFR STATES INTERNAL LITHIUM BATTERY NEEDS REPLACEMENT AS IS AT END OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA IV PUMP FRN SIGMA INTL. 6000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA