BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN LIFT ASSIST BEACH CHAIR

    MDR report key: 24982339 · Received April 24, 2026

    Report

    Report Number
    3006697241-2026-00154
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 24, 2026
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    CCX
    UDI-DI
    00615521004125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 DEVICE WAS RECEIVED FOR EVALUATION AS THE CUSTOMER DECLINED THE REPAIR. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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

    A DISTRIBUTOR CONTACTED TECHNICAL SERVICE TO REPORT THAT BCH CHR POSITION BEACH CHAIR'S BACK PLATE WAS CRACKED. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548287 ALLEN LIFT ASSIST BEACH CHAIR SUPPORT, PATIENT POSITION CCX BAXTER HEALTHCARE CORPORATION AR-1627 00615521004125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown