BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECHRIST HYDRAULIC GURNEY

    MDR report key: 11668080 · Received April 14, 2021

    Report

    Report Number
    2020676-2021-00012
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    October 1, 2019
    Report Date
    April 14, 2021
    Manufacturer
    SECHRIST INDUSTRIES, INC
    Product Code
    FPO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON THE CUSTOMER REPORTED ISSUE. THE HEADREST MALFUNCTIONED BUT DID NOT REQUIRE REPAIR. HISTORICAL DATA DID NOT FIND SIMILAR EVENTS IN THE LAST 24-MONTHS. AT THIS TIME THERE IS NO EVIDENCE 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 NO. (B)(4).

    Description of Event or Problem · 1

    HBO TECH REPORTED, APPROXIMATELY 18 MONTHS AGO, THEY SUFFERED AN INJURY TO THE HAND, WHICH HAND IS UNKNOWN. THIS WAS DUE TO THE COLLAPSE OF STRETCHER PLATE HEADREST WHILE REMOVING A PATIENT FROM THE CHAMBER. THE PATIENT DID NOT SUSTAIN ANY INJURY DURING THE HEADREST COLLAPSE. THE HBO TECHNICIAN'S INJURY RESULTED IN A CUT TO THE HAND AND MILD CRUSH INJURY, WHICH REQUIRED MEDICAL INTERVENTION AND PHYSICAL THERAPY FOLLOWED BY WORKMAN'S COMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565277 SECHRIST HYDRAULIC GURNEY STRETCHER, WHEELED FPO SECHRIST INDUSTRIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention