BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LATITUDE UPPER TELESCOPING ARM

    MDR report key: 22470949 · Received July 10, 2025

    Report

    Report Number
    1824206-2025-01201
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    March 1, 2025
    Report Date
    February 25, 2026
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BAXTER IS IN THE PROCESS OF INSPECTING THE LATITUDE UPPER TELESCOPING ARM BOOM. THERE WAS NO ALLEGATION OF PATIENT OR CAREGIVER INJURY OR DEATH REPORTED FROM THIS ALLEGED INCIDENT. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE DEVICE AT THIS TIME. THE INVESTIGATION IS ONGOING. ALL ADDITIONAL AND RELEVANT INFORMATION THAT IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION WILL BE SUBMITTED IN A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    THE LATITUDE ARM SYSTEM SUPPLIES GAS, ELECTRIC, TELEPHONE AND DATA SERVICES, AND SUPPORT FOR OTHER EQUIPMENT. THE UNIQUE FLEXIBLE DESIGN ALLOWS YOU TO POSITION NEEDED SERVICES AT VARIOUS LOCATIONS WITHIN THE ROOM. THE ARM SYSTEM CAN BE USED IN THE ICU, ED, AND MED-SURG ENVIRONMENTS. BAXTER TECHNICIAN FOUND THE EVENT OCCURRED DUE TO HEALTH PROFESSIONAL CONNECTING THE EXTRACORPOREAL MEMBRANE OXYGENATION INTO ONE OF THE RED OUTLETS ON THE BOOM FACE. THE PATIENT WAS REMOVED FROM THE ROOM WITH NO HARM. SYSTEM WAS INSPECTED BY MAINTENANCE AND THE FIRE DEPARTMENT. INTERNAL COMPONENTS WERE REPLACED BY A MAINTENANCE REPRESENTATIVE FROM THE HOSPITAL. AFTER COMPLETING A THOROUGH INVESTIGATION OF THE AVAILABLE PRODUCT INFORMATION, IT WAS CONFIRMED THAT THIS PRODUCT CODE IS A NON-MEDICAL DEVICE PREVIOUSLY MANUFACTURED AND DISTRIBUTED BY BAXTER. IT DOES NOT MEET THE CRITERIA FOR CLASSIFICATION AS A MEDICAL DEVICE AND, THEREFORE, IS NOT SUBJECT TO THE REQUIREMENTS OF 21 CFR 803, MEDICAL DEVICE REPORTING. THE PRODUCT WAS SOLD TO WITTROCK SEVERAL YEARS AGO, AND THE COMPANY SUBSEQUENTLY CEASED OPERATIONS IN 2020. BASED ON THIS INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    H11: THE RELATED USER FACILITY MEDWATCH REPORT NUMBER (B)(4) IS IN THE CORRESPONDING H10 RELATED REPORT NUMBER FIELD FOR THIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    BAXTER RECEIVED AN FDA VOLUNTARY REPORT WITH NUMBER 4400150000-2025-8026 STATING THAT A FIRE WAS SEEN EXPELLING FROM THE LATITUDE UPPER TELESCOPING BOOM OUTLETS. A CODE RED WAS ANNOUNCED AND THE PATIENT WAS IMMEDIATELY EVACUATED FROM THE ROOM. THERE WAS NO DELAY IN CARE OF THE PATIENT, OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729090 LATITUDE UPPER TELESCOPING ARM LIGHT, SURGICAL, CEILING MOUNTED FSY BAXTER HEALTHCARE CORPORATION P662B N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female NI.