BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XHIBIT TELEMETRY RECEIVER

    MDR report key: 15108612 · Received July 26, 2022

    Report

    Report Number
    3010157426-2022-00020
    Event Type
    Malfunction
    Date Received
    July 26, 2022
    Date of Event
    June 27, 2022
    Report Date
    August 5, 2022
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K141156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SPACELABS TECHNICAL SUPPORT ENGINEER REMOTELY CONNECTED TO THE CUSTOMER'S TELEMETRY SYSTEM AND RESTARTED THE HOST RECEIVER TO RESOLVE THE REPORTED PROBLEM. A SPACELABS PRODUCT SUPPORT SPECIALIST (PSS) REVIEWED LOG FILES AND FOUND THAT ON (B)(6), 2022, A QUAD RECEIVER CARD (QRC) LOCKED UP AND CAUSED THE RECEIVER TO REBOOT. AFTER THE REBOOT, THE RECEIVER WAS UNABLE TO COMMUNICATE WITH ALL QRC'S. THE LOG FILES ALSO CONFIRMED THAT COMMUNICATION WAS RESTORED AFTER THE THE RECEIVER WAS RESTARTED BY THE SPACELABS TECHNICAL SUPPORT ENGINEER. THERE IS NOT ENOUGH INFORMATION AVAILABLE IN THE LOG FILES TO DETERMINE THE EXACT CAUSE OF THE QRC LOCKUP THAT RESULTED IN THE XTR TO REBOOT. THE PSS EDUCATED THE BIOMEDICAL ENGINEER ON HOW TO TEST THE THE QRC CARDS. THE BIOMEDICAL ENGINEER ADVISED THAT HE WOULD PERFORM THE RECOMMENDED TESTING AND ORDER REPLACEMENT QRC CARDS IF NEEDED. THE PSS AND A SPACELABS CUSTOMER PRODUCT RESOLUTION ANALYST ATTEMPTED TO CONTACT THE CUSTOMER TO FOLLOW UP ON THE REPORTED ISSUE AND TESTING RESULTS BUT NO REPLY HAS BEEN RECEIVED. OUR RECORDS INDICATES THAT THERE HAVE BEEN NO ADDITIONAL REPORTS OF THIS ISSUE RECEIVED FROM THE CUSTOMER. SPACELABS HEALTHCARE WILL CONTINUE TO INVESTIGATE THE REPORTED EVENT AND ADDITIONAL INFORMATION WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN AVAILABLE.

    Additional Manufacturer Narrative · 0

    PER SPACELABS PROCEDURE, SPACELABS HAS MADE THREE REQUESTS TO THE CUSTOMER FOR ADDITIONAL INFORMATION REGARDING THE RESULTS OF THE QRC CARD TESTING PERFORMED BY THE BIOMEDICAL ENGINEER IN ORDER TO SUPPORT OUR INVESTIGATION. THE CUSTOMER HAS NOT RESPONDED TO SPACELABS' ATTEMPTS TO COLLECT FURTHER INFORMATION AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. OUR RECORDS INDICATE THERE HAVE BEEN NO ADDITIONAL REPORTS OF THIS ISSUE RECEIVED FROM THE CUSTOMER. THIS REPORT IS COMPLETE, AND THE ISSUE IS CONSIDERED CLOSED.

    Description of Event or Problem · 0

    SPACELABS HEALTHCARE WAS NOTIFIED THAT NINE XHIBIT TELEMETRY RECEIVER (XTR) CHANNELS WENT OFFLINE. THERE IS NO PATIENT HARM REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341352 XHIBIT TELEMETRY RECEIVER TELEMETRY RECEIVER MHX SPACELABS HEALTHCARE 96280

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown