BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT ROOM WALL SAVER RECL

    MDR report key: 3751757 · Received April 15, 2014

    Report

    Report Number
    0001831750-2014-02907
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 24, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FRK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: UNIT IS NOT REPAIRABLE.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY REPLACING THE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE OTTOMAN SECTION IS TWISTED AND WILL NOT CLOSE/LOCK INTO PLACE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE OTTOMAN SECTION IS TWISTED AND WILL NOT CLOSE/LOCK INTO PLACE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229635 PATIENT ROOM WALL SAVER RECL CHAIR, EXAMINATION AND TREATMENT FRK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1