BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPACT MONITOR DISPLAY

    MDR report key: 1002647 · Received February 26, 2008

    Report

    Report Number
    9610816-2008-00011
    Event Type
    Death
    Date Received
    February 26, 2008
    Report Date
    November 19, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHILIPS REMOTE TECHNICAL SUPPORT ENGINEER PROVIDED THE BIOMEDICAL ENGINEER WITH INFO RELATED TO ALARM SUSPEND SETTINGS. THE CUSTOMER HAD INDICATED THAT HAVING THE DEVICE SET UP TO PERMANENTLY SUSPEND ALARMS WAS A FACTOR IN THE PT EXPIRING AS THERE WAS A DELAY IN TREATMENT. POST-INCIDENT, THE HOSP BIOMEDICAL ENGINEER CHANGED THE ALARM SUSPEND SETTINGS ON THE MONITOR TO 3 MINS. NO FORMAL RESPONSE WAS REQUESTED BY THE CUSTOMER. THE INVOLVED DEVICE REMAINS IN USE AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE HOSP BIOMEDICAL ENGINEER CALLED THE REMOTE TECHNICAL ASSISTANCE CENTER (R-TAC) AND REQUESTED INFO REGARDING DEVICE (M3046A) ALARM FUNCTIONALITY WITH REGARD TO ALARM SUSPEND PERIODS. THE BIOMEDICAL ENGINEER ASKED IF ALARMS COULD BE SUSPENDED PERMANENTLY. THE BIOMEDICAL ENGINEER ALSO REPORTED A PT DEATH BUT STATED THAT THE INVOLVED DEVICE WAS OPERATING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT MONITOR DISPLAY M3 PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M3046A

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death