BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XHIBIT TELEMETRY RECEIVER

    MDR report key: 15801923 · Received November 15, 2022

    Report

    Report Number
    3010157426-2022-00027
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    October 16, 2022
    Report Date
    October 19, 2022
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K141156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SPACELABS PRODUCT SUPPORT SPECIALIST (PSS) REVIEWED XTR LOGS AND FOUND EVIDENCE THAT THE CHANNEL WAS UNABLE TO COMMUNICATE WITH A QUAD RECEIVER CARD (QRC). THE PSS WORKED WITH THE HOSPITAL BIOMEDICAL ENGINEER TO EVALUATE THE TELEMETRY SYSTEM AND DISCOVERED TWO FAULTY QRC'S. THERE IS NOT ENOUGH INFORMATION AVAILABLE TO DETERMINE THE EXACT CAUSE OF THE QRC FAILURES. THE PSS DISABLED THE FAULTY QRC'S AND MOVED THE CHANNEL TO PREVENT REOCCURRENCE. THE BIOMEDICAL ENGINEER CONFIRMED THE XTR SYSTEM OPERATED AS EXPECTED AFTER BEING EVALUATED BY THE PSS. THE BIOMEDICAL ENGINEER WAS NOTIFIED THAT THE FAULTY QRC WAS DISABLED AS A TEMPORARY SOLUTION AND ACKNOWLEDGED THAT THE PART WILL BE REPLACED.

    Description of Event or Problem · 0

    SPACELABS HEALTHCARE WAS NOTIFIED THAT XHIBIT TELEMETRY RECEIVER (XTR) BED 6607 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
    172780 XHIBIT TELEMETRY RECEIVER TELEMETRY RECEIVER MHX SPACELABS HEALTHCARE 96280

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown