BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO RESEARCH 3500 MONITOR

    MDR report key: 439736 · Received January 1, 2003

    Report

    Report Number
    1051786-2002-00013
    Event Type
    Malfunction
    Date Received
    January 1, 2003
    Date of Event
    November 27, 2001
    Report Date
    December 31, 2002
    Manufacturer
    INVIVO RESEARCH, INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PULSE OXIMETER READINGS DISPLAYED 69% TO 100% SP02 SATURATION VALUES FROM ANY GIVEN SECOND DEPENDENT ON THE POSITION OF THE MASIMO SP02 SENSOR CABLE. PATIENT REQUIRED INTERVENTION DUE TO AN UNDETECTED LEFT SIDED PNEUMOTHORAX WHICH RESULTED IN AN EMERGENCY BRONCHOSCOPY. THIS PROCEDURE RESOLVED THE PATIENT'S IMMEDIATE RISK. THE SP02 SATURATION VALUES WERE STILL ERRATIC AND REQUIRED A SEPARATE ARTERIAL BLOOD GAS DETERMINATION TO VERIFY THE PATIENT'S BLOOD SATURATION VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO RESEARCH 3500 MONITOR MULTI-PARAMETER PATIENT MONITOR DRT INVIVO RESEARCH, INC. 3500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention MASIMO PULSE OXIMETER SENSORS (UNK).