BEUDAMED
    FDA Adverse Event Death Summary report: N

    TELEHEALTH CENTER PRODUCT LICENSE

    MDR report key: 12412904 · Received September 2, 2021

    Report

    Report Number
    1125873-2021-10000
    Event Type
    Death
    Date Received
    September 2, 2021
    Date of Event
    August 4, 2021
    Manufacturer
    VISICU, INC.
    Product Code
    MSX
    PMA / PMN Number
    K171322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). NO HEALTH CONSEQUENCES OR IMPACT DUE TO THE PERFORMANCE OF DEVICE/SOFTWARE. (B)(4). THE CESSATION OF LIFE. INVESTIGATION CONCLUSION IT WAS ESTABLISHED THAT THE DEVICE/SOFTWARE WAS OPERATING AS INTENDED. THE PATIENT OUTCOME WAS NOT DUE TO THE ALLEGED MALFUNCTION OF THE DEVICE/SOFTWARE. THE INTENT OF THE ELERT IS TO PROVIDE AN ALTERNATE FORM OF COMMUNICATION WITH THE TELEHEALTH COMMUNICATION (THC) (E.G. TELEPHONE) IT IS NOT INTENDED TO REPLACE FACILITY GUIDELINES FOR URGENT SITUATIONS (E.G. BEDSIDE CLINICIAN COMMUNICATES WITH THE FLOOR STAFF FOR ASSISTANCE, FACILITY CODE GUIDELINES.) PER RISK MANAGEMENT MATRIX: ELERT FAILURE 2.2 DATA AVAILABILITY/LOSS OF DATA, PATIENT EXPOSURE TO DATA AVAILABILITY OR LOSS OF DATA DURING CLINICAL USE. SEVERABILITY IS 2 AND THE RISK LEVEL IS ACCEPTABLE. IT IS A KNOWN RISK AND MITIGATION IS ALREADY IDENTIFIED IN THE RISK MATRIX (RMM) FILE AND THERE IS NO ESCALATED RISK. HOWEVER, NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

    Additional Manufacturer Narrative · 0

    1194845 01 AUG 2022 SUPPLEMENTAL REQUIRED. THE RISK IDENTIFICATION SEE RISK MANAGEMENT MATRIX: A-453564843091-1 REV J HAZARD ID 7.9 (PATIENT EXPOSURE TO UNINTENTIONAL USE ERROR OF THE DEVICE DURING CLINICAL USE).DUE TO THE PERFORMANCE OF DEVICE/SOFTWARE. DEATH. INVESTIGATION CONCLUSION: IT WAS ESTABLISHED THAT THE DEVICE/SOFTWARE WAS OPERATING AS INTENDED. THE PATIENT OUTCOME WAS NOT DUE TO THE ALLEGED MALFUNCTION OF THE DEVICE/SOFTWARE.THE INTENT OF THE ELERT IS TO PROVIDE AN ALTERNATE FORM OF COMMUNICATION WITH THE TELEHEALTH CLINICIAN (THC) - EXAMPLE: TELEPHONE, IT IS NOT INTENDED TO REPLACE FACILITY GUIDELINES FOR URGENT SITUATIONS (EXAMPLE: BEDSIDE CLINICIAN COMMUNICATES WITH THE FLOOR STAFF FOR ASSISTANCE, FACILITY CODE GUIDELINES.) PER RISK MANAGEMENT MATRIX: ELERT FAILURE HAZARD IDENTIFICATION 7.9 UNINTENTIONAL USE ERROR, PATIENT EXPOSURE TO UNINTENTIONAL USE ERROR OF THE DEVICE DURING CLINICAL USE. THE PATIENT OUTCOME FOR THIS EVENT WAS DEATH. HOWEVER, ELERT IS AN ALTERNATE COMMUNICATION TOOL PROMINENTLY WALL MOUNTED IN EACH PATIENT ROOM, PROVIDING THE CAPABILITY TO NOTIFY TELEHEALTH CLINICIAN (THC) THROUGH NOTIFICATIONS. THE INTENDED USE OF ECAREMANAGER IS A SOFTWARE TOOL USED IN THE REMOTE SUPPORT TO BEDSIDE TEAMS IN MANAGEMENT OF IN-HOSPITAL PATIENTS. THE DEVICE DID NOT CONTRIBUTE OR CAUSE A DEATH. THE ELERT NOTIFICATION FAILURE COULD NOT HAVE CONTRIBUTED TO THE OUTCOME OF THE PATIENT. THE HARM THAT MAY HAVE POTENTIALLY OCCURRED IS A DELAY IN TREATMENT DUE TO THE DELAY IN CONSULT FROM THE THC. THE SCOPE OF THE DEVICE IS TO NOTIFY AND COMMUNICATE A PATIENT STATUS, THEREFORE, THIS COMPLAINT ASSOCIATED WITH DEATH, WILL BE CONSIDERED IN THE PROBABILITY OF THE HAZARDOUS SITUATION LEADING TO HARM AS A SEVERITY 2. THE RISK LEVEL IS ACCEPTABLE. IT IS A KNOWN RISK AND MITIGATION IS ALREADY IDENTIFIED IN THE RISK MANAGEMENT MATRIX FILE AND THERE IS NO ESCALATED RISK. HOWEVER, NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THE E-LERT BUTTON PRESS IN (B)(6) ON (B)(6) 2021 @ 23:24 UNITED STATES DID NOT NOTIFY THE EICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312165 TELEHEALTH CENTER PRODUCT LICENSE ECAREMANAGER MSX VISICU, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death