BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTATRAK

    MDR report key: 376202 · Received February 6, 2002

    Report

    Report Number
    MW1024039
    Event Type
    Malfunction
    Date Received
    February 6, 2002
    Date of Event
    January 21, 2002
    Report Date
    February 6, 2002
    Manufacturer
    VISUAL IZATION TECHNOLOGY,INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BLACK SCREEN REC'D; REPAIRED BATTERY BACKUP; DATA DOWNLOADED FOR PROCEDURE. MESSAGE REC'D: ATTACH STERILE INSTRUMENTS. WOULD NOT FUNCTION THEREAFTER. MFR INDICATED PROBLEM WITH TRACKING. REPAIRED BUT CAUSED PT TO RETURN FOR SECOND SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTATRAK COMPUTER LLZ VISUAL IZATION TECHNOLOGY,INC. 2000 PIP *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other