BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREATMENT RECLINER

    MDR report key: 6043780 · Received October 20, 2016

    Report

    Report Number
    0001831750-2016-00327
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    September 22, 2016
    Report Date
    March 27, 2018
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FRK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STRYKER ACCOUNT MANAGER INSPECTED THE PRODUCT AND FOUND NO DEFECTS. THE CUSTOMER WAS TRAINED ON HOW TO ENSURE THE SPEED OF THE RISING FOOT REST DOESN'T STARTLE PATIENTS, AND CONFIRMED THAT NO INJURIES WERE REPORTED. THE CUSTOMER DID NOT REQUEST ANY FURTHER FOLLOW UP AT THE TIME.

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO INCLUDE UDI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER IS CONCERNED ABOUT THE FORCE WITH WHICH THE LEG REST ON THE TREATMENT RECLINER OPENS. 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 THAT THE CUSTOMER IS CONCERNED ABOUT THE FORCE WITH WHICH THE LEG REST ON THE TREATMENT RECLINER OPENS. 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 THAT THE CUSTOMER IS CONCERNED ABOUT THE FORCE WITH WHICH THE LEG REST ON THE TREATMENT RECLINER OPENS. 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
    697141 TREATMENT RECLINER CHAIR, EXAMINATION AND TREATMENT FRK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1