BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTIFLEX III CPM

    MDR report key: 1006107 · Received February 21, 2008

    Report

    Report Number
    1022819-2008-00039
    Event Type
    Other
    Date Received
    February 21, 2008
    Date of Event
    January 24, 2008
    Report Date
    February 13, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    BXB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY NOTED DURING THE POST FAILURE INSPECTION OF THE UNIT THAT THE KNEE POTENTIOMETER APPEARED TO HAVE A HAIRLINE CRACK IN THE COMPONENT CASING. CERTIFIED TECHNICAL SERVICE WAS DISPATCHED TO THE CLIENT SITE. THE KNEE POTENTIOMETER WAS REPLACED. THE UNIT WAS RECALIBRATED AND TESTED. THE UNIT OPERATED IN ACCORDANCE WITH PRODUCT SPECIFICATIONS. THE CLIENT DID NOT RETURN THE DEFECTIVE PART TO THE MFR FOR COMPONENT EVALUATION. THIS ISSUE IS TYPICAL TO UNIT MISHANDLING.

    Description of Event or Problem · 1

    UNIT RECENTLY PURCHASED BY CLIENT IS 'LOCKING UP' DURING OPERATION. CLIENT INDICATED THAT THE UNIT WAS IN USE WITH A PT WHEN AT A CERTAIN POINT IN THE TRAVEL OF THE CARRIAGE THE UNIT WOULD UNEXPECTEDLY STOP. THE PT WAS NOT INJURED. DEVICE WAS REMOVED FROM SERVICE FOR REPAIR. THE BIOMED REPORTED THAT THE ISSUE WAS DUPLICATED IN THE REPAIR SHOP. THE BIOMED ALSO REPORTED THAT ONCE THE UNIT WOULD FAIL THE CARRIAGE WOULD FREELY RETURN TO THE 0 DEGREE POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLEX III CPM CONTINUOUS PASSIVE MOTION, LOWER EXTREMITY BXB CHATTANOOGA GROUP 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other