BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 1000 SPDS

    MDR report key: 234633 · Received August 3, 1999

    Report

    Report Number
    1042431-1999-00008
    Event Type
    Malfunction
    Date Received
    August 3, 1999
    Date of Event
    June 15, 1999
    Report Date
    July 30, 1999
    Manufacturer
    ALTHIN MEDICAL AB
    Product Code
    FKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ARTERIAL LEVEL ADJUST SWITCH STUCK INTERMITTENTLY, THE MOTOR STAYED ON AND THE PRIMED SALINE BAG BLEW. NO PATIENT INVOLVEMENT.

    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