BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DT-6012R

    MDR report key: 56243 · Received December 7, 1996

    Report

    Report Number
    8020616-1996-00003
    Event Type
    Malfunction
    Date Received
    December 7, 1996
    Report Date
    December 6, 1996
    Manufacturer
    OHMEDA (S) PTE. LTD.
    Product Code
    DXN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OHMEDA HAS ATTEMPTED AND BEEN UNSUCCESSFUL IN RETRIEVING THE ACTUAL COMPLAINT UNIT. ADD'L INFO HAS BEEN OBTAINED ON THE SET-UP AND SOLUTIONS USED. THE INFO HAS CONFIRMED THAT THE USAGE OF THE DEVICES DID FOLLOW LABELING. THE DIRECTIONS FOR USE INDICATE "OPEN PACKAGE BUT MAINTAIN STERILITY OF MONITORING KIT. VERIFY THAT ALL CONNECTIONS ARE SECURE AND ALL STOPCOCK HANDLES ARE POINTED IN THE DESIRED DIRECTIONS." AS THE COMPLAINT INVESTIGATION COULD NOT CONFIRM THE COMPLAINT, NO CORRECTIVE ACTIONS ARE INDICATED. NO FURTHER INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    SIMULTANEOUSLY THE PT ARRESTED. CURRENT STATUS OF PT AS OF NOVEMBER 11, 1996 WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DT-6012R DISPOSABLE MONITORING KIT DXN OHMEDA (S) PTE. LTD. DT-6012R 9508E088511

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| L| R