BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1032296 · Received April 21, 2008

    Report

    Report Number
    1423500-2008-00269
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 8, 2008
    Report Date
    March 8, 2008
    Manufacturer
    BAXTER HEALTHCARE,
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COVER OF THE DEVICE WAS OPENED AND AN OVERALL GENERAL INTERNAL INSPECTION WAS PERFORMED ON THE DEVICE. NO PROBLEMS WERE REVEALED AND ALL CONNECTIONS APPEARED CORRECT AND SECURE. A TECHNICIAN PERFORMED A VISUAL INSPECTION OF THE POWER ENTRY MODULE. INSPECTION REVEALED THAT THE INSIDE OF POWER ENTRY MODULE WAS CHARRED. THE REPORTED PROBLEM WAS CONFIRMED AND DUPLICATED DURING EVALUATION. THE ASSIGNABLE CAUSE OF THE REPORTED PROBLEM WAS DETERMINED TO BE CHARRED POWER ENTRY MODULE DUE TO EXCESSIVE HEAT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT SMOKING AND THE SMELL OF "BURNING" WITH THE HOME CHOICE (HC) MACHINE DURING SET UP. PER THE INITIAL REPORT, THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HOME PATIENT (HP) TO UNPLUG THE HC; HP WAS NOT CONNECTED TO THE HC. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED 78FKX FKX BAXTER HEALTHCARE,

    Patients

    Seq Age Sex Outcome Treatment
    1