BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEACH CHAIR POSITIONER

    MDR report key: 14285572 · Received May 5, 2022

    Report

    Report Number
    3010216206-2022-00003
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    April 5, 2022
    Report Date
    July 1, 2022
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    CCX
    UDI-DI
    00888867020214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS RECEIVED A REPLACEMENT DEVICE. THE DEVICE INVOLVED IN THIS EVENT IS BEING RETURNED TO THE MANUFACTURER. INVESTIGATION IS ONGOING. HILLROM WILL GATHER ADDITIONAL INFORMATION ON THE CIRCUMSTANCES THAT LEAD TO THE EVENT. ALL ADDITIONAL AND RELEVANT INFORMATION THAT IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION WILL BE SUBMITTED IN A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    ON THE 30TH OF JUNE 2022, ARTHREX, WHO INFORMED HILLROM OF THIS EVENT, COMMUNICATED THAT THEIR CUSTOMER WOULD NOT BE RETURNING THIS DEVICE FOR REPAIR / EVALUATION. THE BEACH CHAIR SHOULDER POSITIONER IS DESIGNED TO POSITION AND SUPPORT THE PATIENT¿S HEAD AND TORSO IN A VARIETY OF SURGICAL PROCEDURES INCLUDED, 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. DO NOT EXCEED 500 LBS. (226 KG) PATIENT WEIGHT. THE SERIAL NUMBER SHOWS THAT THE DEVICE WAS MANUFACTURED IN DECEMBER OF 2014. THIS DEVICE WAS NOT RECEIVED FOR EVALUATION / REPAIR. SINCE THE DEVICE WAS NOT RETURNED, THE ALLEGATION COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE MOST LIKELY ROOT CAUSE OF THE BACKBOARD BREAKING WOULD BE A COMBINATION OF WEAR AND TEAR OF THE DEVICE (DUE TO THE DEVICE BEING OVER TWO YEARS BEYOND ITS DESIGN LIFE) AND CUSTOMER INDUCED DAMAGE. ALTHOUGH THERE WAS NO PATIENT OR CAREGIVER INJURY OR DELAY IN CARE FROM THE REPORTED EVENT, HILLROM CONSIDERS THIS A REPORTABLE EVENT BECAUSE OF THE LIMITED INFORMATION AVAILABLE ON THE MALFUNCTION AND THE POTENTIAL FOR A SERIOUS INJURY IF IT HAD TO RECUR. H3 OTHER TEXT : DEVICE NOT RETURNED BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING AN INTUBATED PATIENT THE BACKBOARD OF A BEACH CHAIR SHOULDER POSITIONER BROKE IN HALF CAUSING THE PATIENT TO FALL BACKWARDS. SURGICAL STAFF IMMEDIATELY CAUGHT THE PATIENT LEADING TO NO INJURY/HARM AND IT IS ADDITIONALLY NOTED THERE WAS NO DELAY IN CARE FROM THE EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING AN INTUBATED PATIENT THE BACKBOARD OF A BEACH CHAIR SHOULDER POSITIONER BROKE IN HALF CAUSING THE PATIENT TO FALL BACKWARDS. SURGICAL STAFF IMMEDIATELY CAUGHT THE PATIENT LEADING TO NO INJURY/HARM AND IT IS ADDITIONALLY NOTED THERE WAS NO DELAY IN CARE FROM THE EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632533 BEACH CHAIR POSITIONER SUPPORT, PATIENT POSITION CCX ALLEN MEDICAL SYSTEMS AR-1627 00888867020214

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown