BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT ROOM WALL SAVER RECL

    MDR report key: 1840387 · Received September 10, 2010

    Report

    Report Number
    1831750-2010-02363
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    STRYKER CORP, MEDICAL DIV.
    Product Code
    FRK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BASED ON PREVIOUSLY REPORTED ADVERSE EVENTS (MANUFACTURER REPORT# 1831750-2010-01872 AND 1831750-2010-01873), AN EVAL WAS PERFORMED ON ALL REMAINING WALL SAVER RECLINERS LOCATED AT THIS FACILITY. THIS EVAL FOUND THAT ONCE THE OTTOMAN WAS RAISED, IT WAS DIFFICULT TO CONSISTENTLY SECURE THE OTTOMAN BACK DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT ROOM WALL SAVER RECL EXAMINATION AND TREATMENT CHAIR FRK STRYKER CORP, MEDICAL DIV. 3500000730 NA

    Patients

    Seq Age Sex Outcome Treatment
    1