BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BILI-LIGHT

    MDR report key: 232024 · Received July 15, 1999

    Report

    Report Number
    232024
    Event Type
    Injury
    Date Received
    July 15, 1999
    Date of Event
    July 9, 1999
    Report Date
    July 14, 1999
    Manufacturer
    OLYMPIC MEDICAL CORP.
    Product Code
    LBI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHOTOTHERAPY UNDERWAY. UNEXPECTEDLY PHOTOTHERAPY BILI-LIGHT COLLAPSED RESULTING IN INJURY/TRAUMA TO HEAD OF NEO-NATE. THE TREATMENT LIGHT HAD NOT BEEN TOUCHED OR MOVED IMMEDIATELY PRIOR TO INCIDENT. THIS EQUIPMENT IS 12 YRS OLD. LAST NORMAL PM WAS DONE MARCH 1999 ON THE REGULAR SCHEDULE. FINDINGS BY BIOMEDICAL ENGINEERS: UNIT HAS A CRACKED PIECE ON THE ARM BRACKET, SCREW LOOSE. THE CRACK APPEARS TO HAVE OCCURRED AT THE TIME OF THIS INCIDENT. THE BILI-LIGHT HAD BEEN IN USE SEVERAL HOURS ON THIS INFANT DAY OF INCIDENT. IMMEDIATE CT SCAN- ABNORMAL BUT NOT CONCLUSIVE. FIRST FOLLOW UP SCAN SUGGESTIVE OF INJURY STILL NOT CONCLUSIVE. CONDITION & REPORT ON NEO-NATE 7/14/99- UNCHANGED. INSPECTION FINDINGS BY BIOMED: ARM VERTICAL STOP (BRACKET) ADJUSTMENT SCREW ALLOWED TOO MUCH MOVEMENT FOR ARM TO SWING DOWNWARD. INVESTIGATION CONCLUSIONS: THE DEVICE WAS THE DIRECT CAUSE OF THE INCIDENT. ARM WITH LAMP ASSEMBLY ALLOWED TO DROP TO A HEIGHT WHERE IT CAN STRIKE A PT. IMMEDIATE ACTIONS REQUIRED: COMPLETE DISASSEMBLY OF ARM AND PIVOT ASSEMBLY. REPLACE ALL DAMAGED PARTS. ADJUST SET SCREW (HEX-HEAD) HIGH ENOUGH WHERE LAMP IS SAFE FROM HITTING PT. ALL MEDICAL DEVICE REPORTS AT FACILITY, ALL RECALLS AND ALERTS WERE REVIEWED TO DETERMINE IF THERE HAD BEEN ANY PREVIOUS REPORTS OF THIS OCCURRENCE. ALL RECORDS 1991- PRESENT WERE CHECKED AND THERE WAS NO OTHER PROBLEMS NOTED. AT THIS TIME THE FACILITY IS NOT RELEASING THIS EQUIPMENT TO THE MFR. HOWEVER, IF THE CO WISHES TO EVALUATE IT, THIS CAN BE DONE IN THE FACILITY'S BIOMEDICAL ENGINEERING DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILI-LIGHT * LBI OLYMPIC MEDICAL CORP. 51470 *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DAY Life Threatening