BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XHIBIT TELEMETRY RECEIVER

    MDR report key: 15396714 · Received September 9, 2022

    Report

    Report Number
    3010157426-2022-00035
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    October 29, 2021
    Report Date
    October 29, 2021
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K141156
    Removal / Correction Number
    3010157426-2022-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SPACELABS HEALTHCARE CEC EVALUATED THE XHIBIT TELEMETRY RECEIVER (XTR) AND CONFIRMED THE REPORTED ISSUE. A SPACELABS HEALTHCARE PRODUCT SUPPORT SPECIALIST (PSS) REVIEWED LOGS AND CONFIRMED THAT TECHNICAL ALARMS WERE CONFIGURED TO ESCALATE PRIORITIES. THE SPACELABS HEALTHCARE PSS REMOTELY RESTARTED ALL XTRS TO RESOLVE THE REPORTED PROBLEM. INVESTIGATION INTO THE REPORTED PROBLEM REVEALED A SOFTWARE BUG THAT PREVENTS ALARM ESCALATION IF THE XHIBIT TELEMETRY RECEIVER HAS BEEN RUNNING FOR LONGER THAN 25 DAYS WITHOUT BEING REBOOTED. SPACELABS HAS ADVISED THE CUSTOMER THAT THEIR ALARM SETTINGS COULD BE ADJUSTED, OR THAT THE XTRS NEED TO BE REBOOTED ROUTINELY, BUT NO LATER THAN 24 DAYS FROM THE LAST RESTART, TO PREVENT RECURRENCE OF THE PROBLEM.

    Description of Event or Problem · 0

    A SPACELABS CLINICAL EDUCATION CONSULTANT (CEC) REPORTED THAT TECHNICAL ALARMS GENERATED FROM THE XHIBIT TELEMETRY RECEIVERS (XTR) ARE NOT ESCALATING PRIORITIES AS EXPECTED. THERE IS NO PATIENT HARM REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307820 XHIBIT TELEMETRY RECEIVER TELEMETRY RECEIVER MHX SPACELABS HEALTHCARE 96280

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown