BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIGHTINGALE PPM (M6)

    MDR report key: 509964 · Received January 5, 2004

    Report

    Report Number
    3003294644-2003-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2004
    Date of Event
    August 19, 2003
    Report Date
    October 30, 2003
    Manufacturer
    ZOE MEDICAL, INC.
    Product Code
    MHX
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SETUP 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 RETURNED THE MONITOR 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 NIGHTINGALE PPM (M6) MULTI-PARAMETER PATIENT MONITOR MHX ZOE MEDICAL, INC. M6 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other