BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRAULIC GURNEY

    MDR report key: 12516077 · Received September 22, 2021

    Report

    Report Number
    2020676-2021-00027
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    September 3, 2021
    Report Date
    September 22, 2021
    Manufacturer
    SECHRIST INDUSTRIES, INC
    Product Code
    FPO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON THE CUSTOMER'S REPORTED ISSUE. BASED ON THE SERVICE RECORDS FOR THIS CUSTOMER, THE LAST PREVENTATIVE MAINTENANCE PERFORMED WAS IN 2017. THE CUSTOMER WAS MADE AWARE THAT ONE OF THE LOCKING MECHANISMS ON THE GURNEY WAS NOT ENGAGING TO SECURE THE STRETCHER PLATE IN THE ELEVATED POSITION. TECHNICIAN RECOMMENDED REPLACEMENT TO THE CURRENT GURNEY MODEL, AS THE MODEL THE CUSTOMER HAD WAS NO LONGER IN PRODUCTION. BASED ON THE SERVICE RECORDS, IT IS UNLIKELY THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE # (B)(4).

    Description of Event or Problem · 1

    DURING THE END OF THE PATIENT TREATMENT, THE HBO TECHNICIAN WENT TO REMOVE THE PATIENT FROM THE CHAMBER, WHEN THE HEADREST COLLAPSED, CAUSING AN INJURY TO THE HBO TECHNICIAN'S THUMB. NO PATIENT INJURY WAS SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414743 HYDRAULIC GURNEY STRETCHER, WHEELED FPO SECHRIST INDUSTRIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1