BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y SENSOR OXISNAP NON-DISPOSABLE OXIMETER PROBE

    MDR report key: 31962 · Received April 11, 1996

    Report

    Report Number
    MW1008856
    Event Type
    Injury
    Date Received
    April 11, 1996
    Date of Event
    November 1, 1995
    Report Date
    April 10, 1996
    Manufacturer
    NOVAMETRIX MEDICAL SYSTEMS, INC.
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EIGHT EVENTS REPORTED SINCE 11/95 OF MINOR RED MARKS NOTED UNDER PULSE OXIMETER PROBES. OPINIONS VARY AS TO WHETHER THESE ARE BURNS OR PRESSURE. IN ONE CASE SLIGHT SKIN BREAKDOWN WAS REPORTED. NO BLISTERS REPORTED. SIMILAR SMDA PREVIOUSLY FILED ON ANOTHER MFR'S NON-DISPOSABLE PULSE OXIMETER PROBE FOR SIMILAR INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Y SENSOR OXISNAP NON-DISPOSABLE OXIMETER PROBE OXIMETER PROBE DQA NOVAMETRIX MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention