BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS CHAIR COUCH

    MDR report key: 1942886 · Received December 23, 2010

    Report

    Report Number
    9611174-2010-00004
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 6, 2010
    Manufacturer
    KEYMED LTD.
    Product Code
    FZK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTEDLY REMOVED THE DEVICE IN SERVICE ALONG WITH THREE OTHER IDENTICAL (NON-FAULTY) DEVICES. THE FAILED DEVICE HAS BEEN RETURNED TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER INVESTIGATION. THE FAILED DEVICE HAS BEEN SENT BY THE OEM TO AN EXTERNAL SPECIALIST TEST HOUSE FOR METALLURGICAL INVESTIGATION. THE EXACT CAUSE OF THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE LATER, THIS REPORT WILL BE UPDATED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED OF A REPORT FROM A USER FACILITY IN (B)(6) INVOLVING AN OLYMPUS CHAIR COUCH (OCC) IN WHICH THE METAL FRAME SUPPORTING THE BACK REST HAD REPORTEDLY SHEARED OFF. THERE WAS NO APPARENT PATIENT INJURY REPORTED; HOWEVER, IF THE REPORTED PHENOMENON WAS TO RECUR, IT IS CONCEIVABLE THAT A PATIENT INJURY MAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS CHAIR COUCH TREATMENT COUCH FZK KEYMED LTD. OLYMPUS OCC NA

    Patients

    Seq Age Sex Outcome Treatment
    1