BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS XHIBIT CENTRAL STATION

    MDR report key: 12872120 · Received November 24, 2021

    Report

    Report Number
    3010157426-2021-00068
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    November 18, 2021
    Report Date
    November 23, 2021
    Manufacturer
    SPACELABS HEALTHCARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K122146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OUR REVIEW OF THE LOGS SHOW THAT AT 4:35:13PM ON NOVEMBER 18, 2021, A USER AT THE XHIBIT CENTRAL STATION MANUALLY DISCHARGED THE PATIENT ADMITTED TO CHANNEL 1102. A SPACELABS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO FURTHER EVALUATE THE REPORTED ISSUE. THE FSE TESTED ALL SPACELABS MONITORING EQUIPMENT INVOLVED IN THE REPORTED EVENT AND OBSERVED PROPER FUNCTIONALITY. WHILE ONSITE, THE FSE EXAMINED THE XTR SYSTEM AND FOUND CHANNEL 1102 IN A PENDING STATUS RATHER THAN ACTIVELY ADMITTED. THE FSE MANUALLY TRANSFERRED THE PENDING INSTANCE TO A DIFFERENT RECEIVER AND THE ADMIT PROCESS IMMEDIATELY BEGAN AT THE XHIBIT CENTRAL STATION. THE LOGS SHOW THAT THIS TRANSFER OCCURRED AT 10:29:36AM ON NOVEMBER 19, 2021. A TRANSMITTER IS PLACED IN A PENDING STATUS WHEN THE CHANNEL HAS BEEN TUNED WITH NO BATTERIES HAVE BEEN PLACED IN THE TRANSMITTER FOR SIGNAL PROCESSING. THE CUSTOMER WAS EDUCATED ON THE PROPER STEPS FOR TUNING A TRANSMITTER AND NOTIFIED THAT THESE INSTRUCTIONS ARE ALSO LISTED IN THE THE XHIBIT CENTRAL STATION WITH TELEMETRY OPERATIONS MANUAL 070-2114-06 REV J. THE INVESTIGATION FINDINGS WERE PROVIDED TO THE CUSTOMER. THIS REPORT IS COMPLETE AND THE ISSUE IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 0

    SPACELABS HAS LAUNCHED AN INVESTIGATION AND WILL FILE A SUPPLEMENTAL REPORT WHEN THE INVESTIGATION IS COMPLETE. H3 OTHER TEXT: PLACEHOLDER.

    Description of Event or Problem · 0

    A SPACELABS FIELD SERVICE ENGINEER (FSE) WAS NOTIFIED THAT TELEMETRY CHANNEL 1102 WAS NOT VISIBLE AT THE XHIBIT CENTRAL STATION AND THAT A PATIENT EXPIRED DURING THIS TIME.

    Description of Event or Problem · 0

    SPACELABS RECEIVED A REPORT ON (B)(6) 2021 INDICATING A PATIENT DIED WHILE NOT BEING ACTIVELY MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770793 SPACELABS XHIBIT CENTRAL STATION XHIBIT CENTRAL MONITOR MHX SPACELABS HEALTHCARE INC. 96102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death