BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE, DOMESTIC 120V

    MDR report key: 1484195 · Received July 24, 2009

    Report

    Report Number
    1423500-2009-00337
    Event Type
    Malfunction
    Date Received
    July 24, 2009
    Date of Event
    July 6, 2009
    Report Date
    July 6, 2009
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) #'S: K0102988 OR K923065.

    Description of Event or Problem · 1

    BAXTER REPORTED THAT A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING NO POWER ON THE HOMECHOICE (HC) UNIT DISPLAY. THIS EVENT OCCURRED BEFORE USE. THE HOME PATIENT (HP) POWERED THE (HC) ON AND THEN THE HC STARTED SMOKING AND HAD A BAD SMELL AND THEN HAD NO POWER. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO UNPLUG MACHINE FROM THE OUTLET AND THE TSR WILL SWAP THE (HC). THE HP HAD MANUAL SUPPLIES AND THE HP WILL HAVE THE REGISTERED NURSE (RN) PROGRAM MACHINE. 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, DOMESTIC 120V 78FKX FKX BAXTER HEALTHCARE NA01

    Patients

    Seq Age Sex Outcome Treatment
    1