BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPIC

    MDR report key: 194901 · Received November 2, 1998

    Report

    Report Number
    194901
    Event Type
    Malfunction
    Date Received
    November 2, 1998
    Date of Event
    October 6, 1998
    Report Date
    November 2, 1998
    Manufacturer
    OLYMPIC MEDICAL CORP.
    Product Code
    LBI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFO BELOW IS TO REPORT A POTENTIAL PROBLEM AND HAS BEEN DISCUSSED WITH THE PRODUCT MFR. PLEASE NOTE THAT THERE HAS NOT BEEN ANY PT ADVERSE EFFECT OR INJURY CAUSED BY THE PRODUCT. THE PRODUCT HAS NOT FAILED. REGARDING: PHOTOTHERAPY LAMPS USED IN THE INTENSIVE CARE NURSERY. AS REPORTED BY CLINICIAN: THE DESIGN OF THE OLYMPIC PHOTOTHERAPY LAMPS ARE SUCH THAT IF THERE IS A FAILURE IN THE SUSPENSION PORTION, THE ARM CAN POTENTIALLY DROP BELOW THE LEVEL OF THE PT AREA OF THE WARMING TABLES (ISOLETTE). THERE IS NO "FAIL-SAFE" DEVICE, SUCH AS A CABLE LOOP, TO PREVENT THE HYPER-EXTENSION OF THE CONNECTING POINTS, SHOULD THE SPRING FAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPIC MINI-BILI LIGHT LBI OLYMPIC MEDICAL CORP. 51477 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *