BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M6 PATIENT MONITORING SYSTEM

    MDR report key: 493310 · Received October 24, 2003

    Report

    Report Number
    1051786-2003-00004
    Event Type
    Malfunction
    Date Received
    October 24, 2003
    Date of Event
    August 19, 2003
    Manufacturer
    INVIVO RESEARCH, INC.
    Product Code
    MHX
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SET UP OF THE MONITOR, THE DENTAL NURSE ASSISTANT NOTICED THE MONITOR DID NOT SOUND ANY AUDIBLE BEEPS DURING THE POWER UP PROCESS. WHEN THE SOUND LEVEL WAS INCREASED TO THE MAXIMUM SETTING, THE AUDIBLE BEEPS STILL COULD NOT BE HEARD. THE CUSTOMER CONTACTED THE MFR AND THE MONITOR WAS ASKED TO BE RETURNED FOR REPAIR. NO PATIENT INJURY OR CLINICAL SITUATION OCCURRED, AS THE FAILURE WAS NOTED BEFORE THE CASE HAD BEGUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M6 PATIENT MONITORING SYSTEM MULTI-PARAMETER PATIENT MONITOR MHX INVIVO RESEARCH, INC. M6 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other