BEUDAMED
    FDA Adverse Event Other Summary report: N

    1550 HEMODIALYSIS MACHINE

    MDR report key: 538801 · Received August 12, 2004

    Report

    Report Number
    1423500-2004-00900
    Event Type
    Other
    Date Received
    August 12, 2004
    Date of Event
    July 15, 2004
    Report Date
    July 15, 2004
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A NURSE STATED THAT WHILE CLEANING THE INSTRUMENT NURSE RECEIVED AN ELECTRICAL SHOCK. NURSE DID NOT REQUIRE FOLLOW UP MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1550 HEMODIALYSIS MACHINE HEMODIALYSIS SINGLE PATIENT SYSTEM, 1550 FII BAXTER HEALTHCARE 1550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other SURGE PROTECTOR (MFR NOT REPORTED) 2004.