BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XHIBIT TELEMETRY RECEIVER

    MDR report key: 18500022 · Received January 11, 2024

    Report

    Report Number
    3010157426-2024-00005
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    December 12, 2023
    Report Date
    December 12, 2023
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K141156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS ABLE TO TEMPORARILY RESOLVE THE FAILURE BY RESEATING THE QUAD RECEIVER CARD (QRC) IN THE XHIBIT TELEMETRY RECEIVER (XTR). THE ISSUE HAS BEEN ISOLATED TO THE XTR, INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THE INITIAL ISSUE WAS DUE TO THE XHIBIT TELEMETRY RECEIVER (XTR) NOT RECOGNIZING ONE OF THE QUAD RECEIVER CARDS (QRC). THE CUSTOMER BIOMED MOVED THE QRC TO A DIFFERENT XTR AND STATED THE ISSUE WAS RESOLVED. THE BIOMED HAS DECLINED ANY FURTHER ASSISTANCE WITH TROUBLESHOOTING AND DECLINED REPAIR AT THIS TIME.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING PATIENT MONITORING, THREE TELEMETRY PATIENTS WENT OFFLINE ON THE XHIBIT CENTRAL STATION. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845382 XHIBIT TELEMETRY RECEIVER XHIBIT TELEMETRY RECEIVER MHX SPACELABS HEALTHCARE 96280

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown