BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOSCOPE II NEONATAL TRANSILLUMINATOR

    MDR report key: 2737454 · Received November 23, 2005

    Report

    Report Number
    2319429-2005-00001
    Event Type
    Malfunction
    Date Received
    November 23, 2005
    Date of Event
    November 2, 2005
    Report Date
    November 10, 2005
    Manufacturer
    VENOSCOPE, LLC
    Product Code
    HJN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DURING ASSEMBLY TWO WIRES ON THE PC BOARD TO THE LED LIGHTS WERE REVERSED. ALTHOUGH THE LIGHT PASSED THE QUALITY CHECK WE DISCOVERED THAT IT WOULD ACCUMULATE HEAT THAT WAS OUT OF SPEC FOR THE DEVICE. WE REPLACED ALL OF THE LIGHTS IN THE AFFECTED BATCH. WE REPLACED THE USER FACILITIES DEVICE AND, UPON INVESTIGATION, WE DISCOVERED THAT THEY RETURNED THE WRONG DEVICE. THAT IS WHY THE SUBJECT LIGHT WAS BRIGHTER THAN THE OTHER 2 LIGHTS THAT THEY HAVE.

    Description of Event or Problem · 1

    INFANT NEEDED IV STARTED. VENOSCOPE II NEONATAL TRANSILLUMINATOR USED TO AID SITE SELECTION. TRANSILLUMINATOR OFF FOR MOST OF THE TIME DURING SITE SELECTION. NURSE CHECKED TEMPERATURE OF LIGHT ON TRANSILLUMINATOR SEVERAL TIMES; LIGHT NOT HOT. HOWEVER, LIGHT WAS HELD IN PLACE FOR 2 MINUTES DURING PROCEDURE. AFTER TASK COMPLETED, AN OPEN AND SLIGHTLY WEEPING AREA NOTED IN FOREARM WITH SCANT SEROUS FLUID AND MILD EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOSCOPE II NEONATAL TRANSILLUMINATOR NEONATAL TRANSILLUMINATOR HJN VENOSCOPE, LLC NT01

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention