BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN LIFT ASSIST BEACH CHAIR

    MDR report key: 21577125 · Received March 11, 2025

    Report

    Report Number
    3010216206-2025-00002
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    February 24, 2025
    Report Date
    March 11, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    CCX
    UDI-DI
    00615521004125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 GAS SHOCK FAILED AND THE BACK BOARD WAS BROKE. BAXTER TECHNICIAN REPLACED THE SHOCK AND BACK BOARD. BEACH CHAIR NOW FUNCTIONS AS IT SHOULD. 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 ALLEN LIFT ASSIST BEACH CHAIR BACKBOARD WERE CRACKED AND WAS RECLINING SLIGHTLY. THE BED WAS LOCATED AT THE ACCOUNT AND OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308938 ALLEN LIFT ASSIST BEACH CHAIR SUPPORT, PATIENT POSITION CCX BAXTER HEALTHCARE CORPORATION A-91501 N/A 00615521004125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown