BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 9310358 · Received November 12, 2019

    Report

    Report Number
    9610816-2019-00300
    Event Type
    Death
    Date Received
    November 12, 2019
    Date of Event
    October 15, 2019
    Report Date
    October 22, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PROBLEM WAS INVESTIGATED VIA REMOTE APPLICATION SPECIALIST (RAS) WHO ESTABLISHED THAT THE NURSE STATES THAT MONITOR DID NOT ALARM FOR SPO2 DESATURATION ON (B)(6) 2019 AROUND 6:15PM FOR BED 2250 - K22501. THE RAS REVIEWED THE CENTRAL STATION LOG FILES THE CUSTOMER PROVIDED AND BROKE IT DOWN TO THE LOGS BETWEEN 5:13PM AND 6:34 PM FOR RED ALARMING FOR BED K22501 WITH RED ALARM SOUNDING AND SILENCING OCCURRING. THE ALARMS WERE TRIGGERED CORRECTLY, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. THE CUSTOMER WAS INSTRUCTED BY THE RAS ACCORDING TO THE LOG FILE REVIEW TO VERIFY THAT THE RED ALARMS DID SOUND AS EXPECTED. NO DEVICE MALFUNCTION OCCURRED. THE INVESTIGATION HAS DEMONSTRATED THAT ALARMS WERE PROVIDED AT THE TIME OF THE EVENT. ADDITIONALLY, THE AVAILABLE INFORMATION FROM THIS REPORT DOES NOT SUPPORT THAT THIS FAILURE REPRESENTS A SYSTEMIC, DESIGN, OR LABELING PROBLEM. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY NEED ASSISTANCE WITH DESAT ALARMING. THE MONITOR DID NOT ALARM FOR SPO2 DESATURATION ON (B)(6) 2019 AROUND 6:15PM FOR BED 2250 - K22501. RESUSCITATION OCCURRED BUT THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107597 INTELLIVUE MULTI MEASUREMENT SERVER X2 PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M3002A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death