BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 1000 SPDS

    MDR report key: 241794 · Received September 23, 1999

    Report

    Report Number
    1042431-1999-00016
    Event Type
    Malfunction
    Date Received
    September 23, 1999
    Date of Event
    August 24, 1999
    Report Date
    September 22, 1999
    Manufacturer
    ALTHIN MEDICAL AB
    Product Code
    FKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BACKFILTRATION. 2-WAY VALVE (J05720S) PROBLEM OCCURRED. PT LOST 1.7 KG IN 2 HOURS AND AFTER 10 MINUTES PUT ON 2.1 KG. THERE WAS NO SERIOUS PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 1000 SPDS SYSTEM 1000 FKP ALTHIN MEDICAL AB SYSTEM 1000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other