BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1243206 · Received November 10, 2008

    Report

    Report Number
    1423500-2008-00900
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKY
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR CODE 2240 THAT OCCURRED ON THE HOME CHOICE (HC) DURING USE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ADVISED TO START OVER WITH NEW SUPPLIES. THE SPOUSE STATED, THE PATIENT LINE DISCONNECTED WHEN THE PATIENT ROLLED OVER IN BED. THE NURSE WAS CONTACTED AND STATED THERE WERE NO REPOTS OF THE EVENT FROM THE PATIENT OR SPOUSE AND THAT THE PATIENT HAD NO INJURIES RELATED TO THE EVENT. THE HC UNIT WAS OPERATIONAL. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG 78FKY FKY BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1