BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER CARDIAC CHAIR

    MDR report key: 5430844 · Received January 21, 2016

    Report

    Report Number
    5430844
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    December 5, 2015
    Report Date
    December 21, 2015
    Manufacturer
    STRYKER
    Product Code
    BYN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PATIENT TRANSFER FROM BED TO CARDIAC CHAIR, THE BED AND CHAIR SEPARATED AND THE PATIENT FELL TO THE FLOOR. STAFF INVOLVED INDICATED THE BED AND CHAIR WERE IN THE "LOCKED" POSITION. PATIENT LANDED ON HER RIGHT SIDE WHERE SHE RECENTLY HAD A RIGHT FEMUR FRACTURE REPAIR WITH HARDWARE. X-RAYS SHOWED A SHIFT IN THE HARDWARE (PINS AND PLATE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43328 STRYKER CARDIAC CHAIR CARDIAC CHAIR BYN STRYKER 5050

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| O| R