BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONAL CYCLER MACHINE 100 VOLTS

    MDR report key: 1972068 · Received January 27, 2011

    Report

    Report Number
    1423500-2011-01135
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:THE DEVICE WAS EVALUATED FOR THE REPORTED CONDITION OF BURNT PART ON THE J4 CONNECTOR. THE RESULTS OF EVALUATION CONFIRMED THAT THERE WAS A PROBLEM ON THE J4 CONNECTOR OF THE ACCOMP BOARD AND HEATER PAN. THE CAUSE WAS UNDETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED. A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510K NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    THE BAXTER TECHNICAL SERVICE CENTER RECEIVED A CYCLER FOR REGULAR MAINTENANCE. DURING MAINTENANCE, THE ENGINEER CONFIRMED THAT THERE WAS A BURNT PART ON THE J4 CONNECTOR OF THE ACCOMP BOARD AND HEATER PAN. THERE WAS NO PATIENT ALLEGATION REGARDING THIS INCIDENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    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