BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT ROOM WALL SAVER RECL

    MDR report key: 1840997 · Received September 10, 2010

    Report

    Report Number
    1831750-2010-02229
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    STRYKER CORP, MEDICAL DIVISION
    Product Code
    FRK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE RECLINER FOUND THAT WHEN LOWERING THE RECLINER TO AN UPRIGHT POSITION, IF THE USER'S HEELS CAME INTO CONTACT WITH THE FOOT TRAY LOCATED BELOW THE OTTOMAN, IT COULD PREVENT THE USER FROM PUSHING THE FOOT SECTION (OTTOMAN) IN FAR ENOUGH FOR IT TO LATCH DOWN. IN ORDER FOR THE MECHANISM TO LATCH IN PLACE CONSISTENTLY, THE USER'S FOOT HAD TO BE PLACED ONLY ON THE FOOT SECTION (OTTOMAN) AND COULD NOT BE TOUCHING THE FOOT TRAY. THE CUSTOMER REQUESTED THAT THE FOOT TRAYS BE REMOVED FROM ALL OF THE WALL SAVER RECLINERS AT THE FACILITY. A DESIGN REVIEW DETERMINED THAT THE FOOT TRAY ASSEMBLY COULD BE REMOVED WITHOUT COMPROMISING THE STRUCTURAL STABILITY OF THE UNIT. IN ADDITION, THE FUNCTION OF THE RECLINE MECHANISM WOULDN'T BE AFFECTED. IT WAS DETERMINED THAT THE REMOVAL OF THE FOOT TRAY ASSEMBLY FROM THE WALL SAVER RECLINER WOULD NOT IMPACT THE FIT, FORM, FUNCTION, OR PERFORMANCE OF THE PRODUCT. THE FOOT TRAY WAS REMOVED AT THE CUSTOMER'S REQUEST.

    Description of Event or Problem · 1

    BASED ON PREVIOUSLY REPORTED ADVERSE EVENTS (MFR 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 RECLINER FRK STRYKER CORP, MEDICAL DIVISION 3500000730 NA

    Patients

    Seq Age Sex Outcome Treatment
    1