BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREATMENT RECLINER

    MDR report key: 4888959 · Received July 2, 2015

    Report

    Report Number
    0001831750-2015-00310
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 4, 2015
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FRK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PARTS ON ORDER FOR REPAIR

    Description of Event or Problem · 1

    IT WAS REPORTED, THE BACKREST WOULD NOT REMAIN UPRIGHT AND COULD NOT SUPPORT PATIENT WEIGHT DUE TO A BROKEN CROSSBAR. 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, THE BACKREST WOULD NOT REMAIN UPRIGHT AND COULD NOT SUPPORT PATIENT WEIGHT DUE TO A BROKEN CROSSBAR. 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
    432002 TREATMENT RECLINER CHAIR, EXAMINATION AND TREATMENT FRK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1