BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIRECUST 1281

    MDR report key: 307387 · Received December 1, 2000

    Report

    Report Number
    1220063-2000-00032
    Event Type
    Other
    Date Received
    December 1, 2000
    Date of Event
    November 5, 2000
    Report Date
    November 30, 2000
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC. EM-P
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    1281 SYSTEM WITH VJ3 SOFTWARE AND SP02 MODULE. THE SP02 ALARM WAS ENABLED AND SET FOR 85 LOW AND 100 HIGH. ON SUNDAY NOV 5TH, IT WAS REPORTED THAT THE PT'S SATURATION LEVEL WENT BELOW FOR AN EXTENDED PERIOD TIME WITHOUT THE SYSTEM GOING INTO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIRECUST 1281 BEDSIDE PATIENT MONITOR DPS SIEMENS MEDICAL SYSTEMS, INC. EM-P 8792129E2501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other