BEUDAMED
    FDA Adverse Event Other Summary report: N

    SERIES S-750 ALTHIN PORTABLE RO

    MDR report key: 274134 · Received April 12, 2000

    Report

    Report Number
    3019131-2000-00004
    Event Type
    Other
    Date Received
    April 12, 2000
    Date of Event
    June 22, 1999
    Report Date
    June 22, 1999
    Manufacturer
    OSMONICS, INC. (ZYZATECH) / KENT OPERATIONS
    Product Code
    JRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE WHEEL OF THE EQUIPMENT FELL OFF, CAUSING THE MACHINE TO TILT. THE OPERATOR ATTEMPTED TO STOP THE MACHINE FROM TILTING, INJURING HER SHOULDER IN THE PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES S-750 ALTHIN PORTABLE RO PORTABLE WATER PURIFICATION FOR HEMODIALYSIS, RO JRS OSMONICS, INC. (ZYZATECH) / KENT OPERATIONS S-750 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability