BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLE, OPERATING ROOM / BEACH CHAIR ATTACHMENT

    MDR report key: 6996124 · Received November 2, 2017

    Report

    Report Number
    MW5073101
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    October 13, 2017
    Report Date
    October 31, 2017
    Manufacturer
    SKYTRON
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PT SCHEDULED FOR ARTHROSCOPIC IRRIGATION AND DEBRIDEMENT LEFT SHOULDER. IN OPERATING ROOM, PT WAS PUT IN BEACH CHAIR POSITION WITH ARTHREX BEACH CHAIR ATTACHMENT WITH HIS HEAD IN HEAD HOLDER. BLOOD PRESSURE DROPPED. SKYTRON OPERATING ROOM TABLE WAS MOVED TO TRENDELENBURG POSITION AND BLOOD PRESSURE WAS TREATED. AFTER BLOOD PRESSURE INCREASED, ATTEMPT WAS MADE TO LEVEL BED SO PT COULD BE POSITIONED FOR SURGERY. DURING LEVELING PROCESS, THE BEACH CHAIR ATTACHMENT OF THE OPERATING ROOM TABLE BECAME DETACHED FROM THE MAIN PORTION OF THE OPERATING ROOM TABLE WHILE THE PT WAS ATTACHED TO IT. THE STAFF IN THE ROOM WERE ABLE TO IMMEDIATELY SUPPORT THE PT'S UPPER BODY WHEN THIS OCCURRED. PRECAUTIONS WERE IMMEDIATELY IMPLEMENTED AND TESTING WAS COMPLETED TO ENSURE PT WAS NOT INJURED. AFTER THE TESTING CONFIRMED THAT PT WAS NOT INJURED AND THAT IT WAS SAFE TO PROCEED, THE SHOULDER SURGERY WAS COMPLETED THE SAME DAY. ROOT CAUSE ANALYSIS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776429 TABLE, OPERATING ROOM / BEACH CHAIR ATTACHMENT BEACH CHAIR ATTACHMENT FQO SKYTRON

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention