BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEACH CHAIR POSITIONER

    MDR report key: 19867989 · Received July 30, 2024

    Report

    Report Number
    3010216206-2024-00009
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    June 18, 2024
    Report Date
    October 2, 2024
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. BAXTER IS IN THE PROCESS OF INSPECTING THE AR-1627 BEACH CHAIR POSITIONER. THERE WAS NO ALLEGATION OF PATIENT OR CAREGIVER INJURY OR DEATH REPORTED FROM THIS ALLEGED INCIDENT. 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 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 SHOULDER POSITIONER WAS RECEIVED BY BAXTER. UPON INSPECTION, IT WAS DETERMINED THAT THE KNOBS TO LOCK TO THE FIXTURE WERE DAMAGED CAUSING THE RUPTURE OF THE BEACH CHAIR BACKBOARD . THE 4 LOBE BLACK KNOBS TO LOCK TO THE FIXTURE, BEACH CHAIR BACKBOARD, VELCRO AND SCREW COVERS 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 BROKEN BEACH CHAIR POSITIONER BACK PANEL WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING A TOTAL SHOULDER ARTHROPLASTY PROCEDURE, AN AR-1627 BEACH CHAIR POSITIONER WAS BROKEN ON THE PANEL ON THE BACK, LEADING THE HYDRAULIC NOT TO WORK AND COMPLETELY COLLAPSE. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING A TOTAL SHOULDER ARTHROPLASTY PROCEDURE, AN AR-1627 BEACH CHAIR POSITIONER WAS BROKEN ON THE PANEL ON THE BACK, LEADING THE HYDRAULIC NOT TO WORK AND COMPLETELY COLLAPSE. NO HARM OR SIGNIFICANT IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215579 BEACH CHAIR POSITIONER SUPPORT, PATIENT POSITION CCX ALLEN MEDICAL SYSTEMS AR-1627

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown