BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREATMENT RECLINER

    MDR report key: 3757390 · Received April 17, 2014

    Report

    Report Number
    0001831750-2014-02918
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FRK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE RECLINER BACKREST WAS BROKEN AND WOULD NOT SUPPORT PATIENT WEIGHT. SUPPLEMENTAL SUBMITTED AS FURTHER INVESTIGATION DETERMINED THE BACKREST WOULD LEAN BACK WHEN WEIGHT WAS APPLIED TO THE BACKREST, DUE TO SPONGY BACKREST. THIS WOULD RESULT IN CAREGIVER ANNOYANCE ADDITIONALLY, IT IS NOT LIKELY TO HARM THE PATIENT AS AND 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 WAS BROKEN AND WOULD NOT SUPPORT PATIENT WEIGHT. 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 WAS BROKEN AND WOULD NOT SUPPORT PATIENT WEIGHT. 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
    235780 TREATMENT RECLINER CHAIR, EXAMINATION AND TREATMENT FRK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1