BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT ROOM ROCKER RECLINER

    MDR report key: 4916555 · Received July 15, 2015

    Report

    Report Number
    0001831750-2015-00354
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    June 20, 2015
    Report Date
    June 20, 2015
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FRK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED WITH ADDITIONAL INFORMATION PROVIDED BY CUSTOMER'S EVALUATION. REVISED EXECUTIVE SUMMARY TO STATE THE RECLINER WOULD NOT LOCK IN THE CLOSED POSITION DUE TO A BENT MECHANISM. CONCLUSION - PART WAS SENT TO CUSTOMER TO PERFORM REPAIR. CUSTOMER PERFORMED EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT RECLINER GAVE WAY WITH A PATIENT IN THE RECLINER. 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 RECLINER GAVE WAY WITH A PATIENT IN THE RECLINER AND WOULD NOT LOCK IN THE CLOSED POSITION DUE TO A BENT MECHANISM. THE PATIENT WAS NOT AFFECTED, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461343 PATIENT ROOM ROCKER RECLINER CHAIR, EXAMINATION AND TREATMENT FRK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1