BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIM BCI OXYGEN SATURATION MONITOR

    MDR report key: 315660 · Received February 1, 2001

    Report

    Report Number
    315660
    Event Type
    Malfunction
    Date Received
    February 1, 2001
    Date of Event
    January 1, 2000
    Report Date
    January 31, 2001
    Manufacturer
    SIMS BCI, INC
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LOW SPEAKER VOLUME X 2 UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4041 SIM BCI OXYGEN SATURATION MONITOR OXYGEN SATURATION MONITOR DQA SIMS BCI, INC 3303NV *

    Patients

    Seq Age Sex Outcome Treatment
    1 *