BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEACH CHAIR POSITIONER

    MDR report key: 4664984 · Received March 30, 2015

    Report

    Report Number
    MW5041907
    Event Type
    Malfunction
    Date Received
    March 30, 2015
    Date of Event
    March 18, 2015
    Report Date
    March 30, 2015
    Manufacturer
    SKYTRON
    Product Code
    GBB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BEACH CHAIR POSITIONER (SKYTRON). PATIENT PLACED ON HERCULES OPERATING ROOM BED, WITH THE BEACH CHAIR ATTACHMENT SECURELY AND PROPERLY ATTACHED. THE ATTACHMENT BROKE IN THE LOWER BACK PORTION OF THE COMPOSITE BOARD (TOTALLY ACROSS DEVICE) AND METAL SUPPORTING BARS PRIOR TO THE INITIATION OF ANESTHESIA. THE PATIENT SLID OFF HEAD FIRST TOWARDS THE OPERATING ROOM FLOOR. THE PATIENT'S HEAD AND NECK WAS SUPPORTED BY OPERATING ROOM STAFF BUT PATIENT FELL TO THE FLOOR WITH CONTACT AFFECTING THE UPPER BACK AND BILATERAL SHOULDERS. POST EVENT, THE PATIENT COMPLAINED OF LEFT SHOULDER PAIN, NO INJURY DETERMINED AT THAT TIME. DEVICE REPORTED WEIGHT LIMIT (B)(6), PATIENT CONFIRMED AND VERIFIED WEIGHT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209110 BEACH CHAIR POSITIONER BEACH CHAIR POSITIONER GBB SKYTRON

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR SKYTRON HERCULES 6701 O.R. BED