BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSMONICS F801 RO SYSTEM

    MDR report key: 356166 · Received October 13, 2001

    Report

    Report Number
    3019131-2001-00001
    Event Type
    Malfunction
    Date Received
    October 13, 2001
    Report Date
    September 14, 2001
    Manufacturer
    OSMONICS, INC.
    Product Code
    JRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTS THAT THE CASTERS ON THE MEDICAL DEVICE ARE "COLLAPSING" UNDER RIGOROUS USE. MEDICAL DEVICES ARE TRANSPORTED TO, AND USED AT, 13 SEPARATE FACILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46160 OSMONICS F801 RO SYSTEM REVERSE OSMOSIS WATER PURIFICATION SYSTEM FOR HEMODIALYSIS. JRS OSMONICS, INC. 12340 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other