BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS IC2

    MDR report key: 14986089 · Received July 12, 2022

    Report

    Report Number
    3003832357-2022-00016
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    April 4, 2022
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES (RDT)
    Product Code
    MWI
    PMA / PMN Number
    K152124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    AS REPORTED BY THE CUSTOMER 'THE TEMPUS IC2 INVOLVED IS EXHIBITING CONNECTIVITY ISSUES. A RED NETWORK STATUS IS SHOWN, ALONG WITH CONNECTIVITY FAILURE ACROSS ALL 3 SERVERS'. THE FAILURE IS WITH THE I2I SOFTWARE WHICH PROVIDES THE CONNECTIVITY WITH THE SERVER AND NOT WITH THE TEMPUS IC2 DEVICE. THE I2I SERVER FAILURE HAS BEEN FIXED AND THE UPDATED WATCHDOG SOFTWARE HAS BEEN DEPLOYED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670272 TEMPUS IC2 PATIENT MONITOR MWI REMOTE DIAGNOSTIC TECHNOLOGIES (RDT)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown