BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEACH CHAIR H

    MDR report key: 23853523 · Received December 19, 2025

    Report

    Report Number
    3006697241-2025-00342
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 19, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    CCX
    UDI-DI
    00888867020214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BEACH CHAIR SHOULDER POSITIONER IS DESIGNED TO POSITION AND SUPPORT THE PATIENT¿S HEAD AND TORSO IN A VARIETY OF SURGICAL PROCEDURES INCLUDING, BUT NOT LIMITED TO ORTHOPEDIC SURGERIES LIKE, ROTATOR CUFF, TOTAL SHOULDER, REVERSE TOTAL SHOULDER, SLAP REPAIR AND OTHER SHOULDER SURGERY. THESE DEVICES ARE INTENDED TO BE USED BY HEALTHCARE PROFESSIONALS WITHIN THE OPERATING ROOM SETTING. THE BEACH CHAIR WAS RECEIVED BY BAXTER. UPON INSPECTION, IT WAS DETERMINED THAT THE BACKBOARD WAS CRACKED IN THE UPPER PORTION. BACKBOARD, SCREW COVERS AND VELCRO WERE REPLACED. BASED ON THIS INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF A BEACH CHAIR BACKBOARD BEING CRACKED WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS EVENT.

    Description of Event or Problem · 0

    BAXTER RECEIVED A REPORT STATING THAT BEACH CHAIR HAD A CRACK IN THE FIBERGLASS BACK SECTION WHEN A PATIENT WAS POSITIONED. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251902 BEACH CHAIR H SUPPORT, PATIENT POSITION CCX BAXTER HEALTHCARE CORPORATION 2077600 N/A 00888867020214

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.