BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XHIBIT TELEMETRY RECEIVER

    MDR report key: 15936771 · Received December 7, 2022

    Report

    Report Number
    3010157426-2022-00054
    Event Type
    Malfunction
    Date Received
    December 7, 2022
    Date of Event
    November 8, 2022
    Report Date
    November 8, 2022
    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

    A SPACELABS PRODUCT SUPPORT SPECIALIST (PSS) REVIEWED LOGS AND FOUND THAT ALL NINE IDENTIFIED CHANNELS WERE HOSTED BY THE SAME RECEIVER. THE LOGS ALSO SHOWED EVIDENCE THAT THE RECEIVER WAS UNABLE TO COMMUNICATE WITH QUAD RECEIVER CARD (QRC) 3 FOLLOWING AN UNEXPECTED RESTART ON (B)(6) 2022. THERE IS NOT ENOUGH INFORMATION AVAILABLE IN THE LOG FILES TO DETERMINE THE EXACT CAUSE OF THE COMMUNICATION ISSUES BETWEEN THE XTR AND QRC. A SPACELABS FIELD SERVICE (FSE) WAS DISPATCHED TO FURTHER EVALUATE THE TELEMETRY SYSTEM. THE FSE RESTARTED THE HOST RECEIVER TO RESOLVE THE REPORTED ISSUE. ALTHOUGH RESTARTING THE RECEIVER RESOLVED THE REPORTED ISSUE, THE ROOT CAUSE COULD NOT BE DETERMINED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56.

    Description of Event or Problem · 0

    SPACELABS HEALTHCARE WAS NOTIFIED THAT NINE BEDS CONNECTED TO THE XHIBIT TELEMETRY RECEIVER (XTR) SYSTEM WENT OFFLINE UNEXPECTEDLY. THERE IS NO PATIENT OR USER HARM REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444523 XHIBIT TELEMETRY RECEIVER TELEMETRY RECEIVER MHX SPACELABS HEALTHCARE 96280

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization