BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPITAL RECLINER CHAIR

    MDR report key: 3122066 · Received May 21, 2013

    Report

    Report Number
    0001831750-2013-04565
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FRK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED TO UPDATE THE CONCLUSION CODE. FURTHER INVESTIGATION DETERMINED THE CASTERS WERE NOT HOLDING PROPERLY AND WERE NON-STRYKER COMPONENTS. THE CASTERS ON THE CHAIR WERE REPLACED WITH THE APPROPRIATE STRYKER COMPONENTS.

    Additional Manufacturer Narrative · 1

    CONCLUSION: UNIT TO BE REPAIRED AT A LATER DATE; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FRONT CASTORS WERE NOT HOLDING WHEN THE LOCKS WERE ENGAGED. 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 FRONT CASTORS WERE NOT HOLDING WHEN THE LOCKS WERE ENGAGED. 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
    223899 HOSPITAL RECLINER CHAIR CHAIR, EXAMINATION AND TREATMENT FRK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1