BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U1104 1550 SINGLE PATIENTSYSTEM

    MDR report key: 1231097 · Received May 23, 2007

    Report

    Report Number
    1423500-2007-00014
    Event Type
    Malfunction
    Date Received
    May 23, 2007
    Date of Event
    April 25, 2007
    Report Date
    April 30, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKP
    PMA / PMN Number
    K883111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED THAT A NURSE SAID THAT THERE WAS INTERMITTENT POWER LOSS WITHOUT AN ALARM ON A 1550 DEVICE DURING THERAPY. THE 1550 DEVICE THEN POWERED ITSELF BACK ON. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) RECOMMENDED THAT THE TECHNICIAN SHOULD BRING THE 5 VOLT POWER SUPPLY WITHIN RANGE AND MONITOR THE 5 VOLT POWER SUPPLY. THE TECHNICIAN CONFIRMED THAT ADJUSTING THE 5 VOLT POWER SUPPLY CORRECTED THE ISSUE, AND THE DEVICE WAS RETURNED TO SERVICE BY THE FACILITY. THE PT WAS CONNECTED TO THE DEVICE AT THE TIME OF THE INCIDENT. THE PT'S BLOOD WAS RETURNED TO THE PT. THERAPY WAS COMPLETED ON ANOTHER DEVICE. NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U1104 1550 SINGLE PATIENTSYSTEM 78FKP FKP BAXTER HEALTHCARE CORPORATION 5M5538 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK