BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREATMENT RECLINER

    MDR report key: 3120387 · Received May 20, 2013

    Report

    Report Number
    0001831750-2013-04542
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FRK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION DETERMINED THE BACKREST NOT STAYING UP WOULD RESULT IN CAREGIVER 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 BACKREST WOULD NOT SUPPORT WEIGHT AS THE ATTACHMENT KNOB WAS OUT OF ALIGNMENT. 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 BACKREST WOULD NOT STAY UP AS THE CUSTOMER HAD INSTALLED THE BACKREST SCREWS IN THE WRONG MOUNTING HOLES. 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
    221876 TREATMENT RECLINER CHAIR, EXAMINATION AND TREATMENT FRK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1