BEUDAMED
    FDA Adverse Event Death Summary report: N

    RNS-9703-242

    MDR report key: 12434003 · Received September 7, 2021

    Report

    Report Number
    2080783-2021-01640
    Event Type
    Death
    Date Received
    September 7, 2021
    Date of Event
    August 13, 2021
    Report Date
    September 7, 2021
    Manufacturer
    NKUS LAB
    Product Code
    MHX
    UDI-DI
    00851725007122
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT UPON REVIEWING A PATIENTS DATA WHO HAS JUST RECENTLY PASSED AWAY THEY DETERMINED THAT THE INCORRECT TIME WAS NOTED ON ALL OF THE INFORMATION WHEN VIEWED FROM THE REMOTE NETWORK STATION (RNS). THEY ALSO STATED THAT THEY WERE ABLE TO PHYSICALLY VIEW THE EVENT OF WHEN THE PATIENT PASSED AWAY ON THIS RNS, DESPITE IT HAPPENING EARLIER IN THE DAY. THE EVENT DID ALARM ON THE BEDSIDE MONITOR (BSM) AND THE DEPARTMENTS MAIN CENTRAL NURSE'S STATION (CNS). THE RNS ALSO ALARMED, BUT DUE TO IT BEING ON THE INCORRECT TIME, THE ALARM WAS DELAYED. THE CUSTOMER CONFIRMED THAT THE PATIENT DEATH WAS ANTICIPATED AND NOT DUE TO THE RNS MALFUNCTION. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: ATTEMPT #: ON (B)(6) 2021 EMAILED CUSTOMER VIA (B)(6) FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. AN "UNKNOWN" REPLY WAS RECEIVED. THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE RNS, BUT DID NOT EXPERIENCE A FAILURE: BSM - MODEL: NI, S/N: NI, APPROXIMATE AGE OF THE DEVICE: NI, DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: NI. CNS - MODEL: NI, S/N: NI, APPROXIMATE AGE OF THE DEVICE: NI, DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: NI.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT UPON REVIEWING A PATIENTS DATA WHO HAS JUST RECENTLY PASSED AWAY THEY DETERMINED THAT THE INCORRECT TIME WAS NOTED ON ALL OF THE INFORMATION WHEN VIEWED FROM THE REMOTE NETWORK STATION (RNS). THEY ALSO STATED THAT THEY WERE ABLE TO PHYSICALLY VIEW THE EVENT OF WHEN THE PATIENT PASSED AWAY ON THIS RNS, DESPITE IT HAPPENING EARLIER IN THE DAY. THE EVENT DID ALARM ON THE BEDSIDE MONITOR (BSM) AND THE DEPARTMENTS MAIN CENTRAL NURSE'S STATION (CNS). THE RNS ALSO ALARMED, BUT DUE TO IT BEING ON THE INCORRECT TIME, THE ALARM WAS DELAYED. THE CUSTOMER CONFIRMED THAT THE PATIENT DEATH WAS ANTICIPATED AND NOT DUE TO THE RNS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332994 RNS-9703-242 REMOTE NETWORK STATION MHX NKUS LAB RNS-9703-242 NA 00851725007122

    Patients

    Seq Age Sex Outcome Treatment
    1 Death BEDSIDE MONITOR (BSM)| CENTRAL NURSE'S STATION (CNS)