BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1550 HEMODIALYSIS MACHINE

    MDR report key: 1201224 · Received October 20, 2008

    Report

    Report Number
    1423500-2007-00073
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    January 1, 2007
    Report Date
    January 16, 2007
    Manufacturer
    LARGO
    Product Code
    FKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON FEB 15, 2007. THE INSTRUMENT WAS NOT MADE AVAILABLE FOR EVALUATION BY BAXTER. THE INSTRUMENT WAS FIXED AT THE CUSTOMER LOCATION BY THE FACILITY'S BIOMEDICAL TECHNICIAN AND RETURNED BACK INTO SERVICE. BAXTER IS MONITORING ISSUES LIKE THAT. IF ADDITIONAL INFORMATION IS DISCOVERED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO GLOBAL TECHNICAL SERVICE INTERMITTENT POWER FAILURE WITHOUT ALARM DURING HD TREATMENT. THE BIOMED TECHNICIAN REPORTED THAT, ACCORDING TO THE CLINICAL STAFF, 1550 INSTRUMENT SHUTS OFF WITHOUT ALARM, AND TURNS ITSELF BACK ON. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1550 HEMODIALYSIS MACHINE HEMODIALYSIS SINGLE PATIENT SYSTEM, 1550 FKP LARGO 5M5538

    Patients

    Seq Age Sex Outcome Treatment
    1