BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREATMENT RECLINER

    MDR report key: 4888869 · Received July 2, 2015

    Report

    Report Number
    0001831750-2015-00308
    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

    FOLLOW-UP SUBMITTED TO CORRECT THE PREVIOUS CONCLUSION CODE. THE DEVICE WAS NOT REPAIRED AND RETURNED AS THE UNIT HAS NOT BEEN AVAILABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE IT IS OBTAINED.

    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.

    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
    432488 TREATMENT RECLINER CHAIR, EXAMINATION AND TREATMENT FRK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1