BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XHIBIT TELEMETRY RECEIVER

    MDR report key: 15760425 · Received November 9, 2022

    Report

    Report Number
    3010157426-2022-00052
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 8, 2022
    Report Date
    October 10, 2022
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K141156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SPACELABS PRODUCT SUPPORT SPECIALIST (PSS) REVIEWED XTR LOGS AND FOUND THE CHANNEL TUNED TO XTR19 AND UNABLE TO COMMUNICATE WITH A QUAD RECEIVER CARD (QRC). THE PSS DISABLED THE QRC AND MOVED THE CHANNEL TO PREVENT RECURRENCE. THE PSS WORKED WITH A HOSPITAL BIOMEDICAL ENGINEER TO EVALUATE THE TELEMETRY SYSTEM AND THE REPORTED ISSUE COULD NOT BE REPLICATED. THE QRC WAS FOUND TO BE WORKING AS EXPECTED. AT THIS TIME, THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    SPACELABS HEALTHCARE WAS NOTIFIED THAT XHIBIT TELEMETRY RECEIVER (XTR) BED 6648 DISAPPEARED FROM BOTH XHIBIT CENTRAL STATIONS. THERE IS NO PATIENT OR USER HARM REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2432175 XHIBIT TELEMETRY RECEIVER TELEMETRY RECEIVER MHX SPACELABS HEALTHCARE 96280

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown