BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT ROOM WALL SAVER RECL

    MDR report key: 3722691 · Received April 2, 2014

    Report

    Report Number
    0001831750-2014-02843
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    October 30, 2013
    Report Date
    March 10, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FRK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT A PATIENT ALLEGEDLY FELL BACKWARD IN THE RECLINER HITTING THEIR LEG ON A BEDSIDE TABLE ALLEGEDLY DUE TO THE BACK OF THE RECLINER BEING LOOSE. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198697 PATIENT ROOM WALL SAVER RECL CHAIR, EXAMINATION AND TREATMENT FRK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1