BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREATMENT RECLINER

    MDR report key: 3793666 · Received May 6, 2014

    Report

    Report Number
    0001831750-2014-02960
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FRK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION DETERMINE THE BACKREST WAS FOUND TO BE STUCK IN THE RECLINER POSITION. THIS WOULD RESULT IN ANNOYANCE; HOWEVER, THE CAREGIVER WOULD STILL BE ABLE TO ASSIST THE PATIENT, IF NECESSARY. ADDITIONALLY, IT IS NOT LIKELY TO HARM THE PATIENT AS THE RECLINER WOULD STILL SUPPORT WEIGHT. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WAS TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE RECLINER BACKREST WOULD NOT SUPPORT PATIENT WEIGHT DUE TO BROKEN REAR CROSS BAR. 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 RECLINER BACKREST WOULD NOT SUPPORT PATIENT WEIGHT DUE TO BROKEN REAR CROSS BAR. 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
    272358 TREATMENT RECLINER CHAIR, EXAMINATION AND TREATMENT FRK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1