BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONAL CYCLER MACHINE 100 VOLTS

    MDR report key: 1893896 · Received November 9, 2010

    Report

    Report Number
    1423500-2010-05494
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: THE TECHNICAL SERVICE CENTER RECEIVED THE ACTUAL SAMPLE FOR EVALUATION. THE ENGINEER PERFORMED AN EVALUATION BASED ON THE FAILURE ANALYSIS PROCEDURE. THE ENGINEER CONFIRMED THAT THERE WAS A PROBLEM ON THE POWER ENTRY MODULE. THE ROOT CAUSE WAS DETERMINED TO BE A HARDWARE PROBLEM WITH A DEFECT OF THE ACCOMP BOARD AND HEATER PAN. THE POWER ENTRY MODULE WAS REPLACED AND THE INSTRUMENT THEN MET ALL SPECIFICATIONS. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR PRODUCT LINES FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE EVALUATION IS IN PROCESS. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    A (B)(6) PATIENT, AFTER POWERING ON THE HOMECHOICE (HC) DEVICE, REPORTED THAT THE POWER SHUT DOWN. IT WAS ALSO REPORTED THAT THE POWER BUTTON DID NOT WORK, THE NAVIGATIONAL PANEL WAS OFF AND AFTER PLUGGING IN AND UNPLUGGING THE DEVICE SEVERAL TIMES THE POWER ISSUE WAS NOT RESOLVED. THE TECHNICAL SERVICE CENTER RECEIVED THE ACTUAL SAMPLE FOR ROUTINE MAINTENANCE. AS PART OF THE MAINTENANCE EVALUATION, A TECHNICIAN CONFIRMED AND NOTED A BURNT PORTION OF THE POWER MODULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERSONAL CYCLER MACHINE 100 VOLTS SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1