BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONAL CYCLER MACHINE 100 VOLTS

    MDR report key: 1984202 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01753
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 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 TECHNICAL SERVICE CENTER RECEIVED THE ACTUAL SAMPLE FOR EVALUATION. THE ENGINEER CONFIRMED THAT THERE WAS A PROBLEM ON THE J4 CONNECTOR OF THE ACCOMP BOARD AND HEATER PAN, THEREFORE, THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THIS PROBLEM SEEMED TO HAVE BEEN THE DEFECT OF THE J4 CONNECTOR OF THE ACCOMP BOARD AND HEATER PAN. THE J4 CONNECTOR OF THE ACCOMP BOARD AND HEATER PAN WERE REPLACED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. CORRECTION: THE FOLLOWING INFORMATION WAS ERRONEOUSLY OMITTED FROM THE INITIAL MEDWATCH: THIS DEVICE IS DISTRIBUTED 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.

    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.

    Description of Event or Problem · 1

    THE TECHNICAL SERVICE CENTER RECEIVED A HOMECHOICE MACHINE FOR REGULAR MAINTENANCE. DURING MAINTENANCE, THE ENGINEER CONFIRMED THAT THERE WAS A BURNT PART ON THE CAPACITOR OF THE DIGITAL BOARD. THERE WAS NO ALLEGATION ABOUT THE BURNT PART FROM THE CUSTOMER. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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