BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    700 SERIES PORTABLE RO SYSTEM

    MDR report key: 178685 · Received July 20, 1998

    Report

    Report Number
    3019131-1998-00001
    Event Type
    Malfunction
    Date Received
    July 20, 1998
    Date of Event
    June 15, 1998
    Report Date
    June 19, 1998
    Manufacturer
    ZYZATECH WATER SYSTEMS, INC.
    Product Code
    JRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE MOVING A PORTABLE REVERSE OSMOSIS MACHINE IN A DIALYSIS UNIT, ONE OF THE WHEELS CAME OFF, AND THE MACHINE TIPPED. THE OPERATOR, IN ATTEMPTING TO PREVENT THE MACHINE FROM FALLING OVER, SUSTAINED A BACK INJURY. THE OPERATOR MISSED TWO DAYS WORK, AND WAS PLACED ON MODIFIED WORK DUTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 700 SERIES PORTABLE RO SYSTEM REVERSE OSMOSIS WATER PURIFICATION FOR HEMODIALYSIS JRS ZYZATECH WATER SYSTEMS, INC. 14524 303606

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other