BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBILE EXAMINATION LIGHT F 300, LED, DIMMABLE, W/EXTRA WEIGHT, 100-120 V(AC) W/S

    MDR report key: 8994879 · Received September 11, 2019

    Report

    Report Number
    0008010153-2019-00013
    Event Type
    Injury
    Date Received
    September 11, 2019
    Date of Event
    August 16, 2019
    Report Date
    November 20, 2019
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    KZF
    UDI-DI
    07613327296167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL IS BEING SUBMITTED TO UPDATE THE MDR CATALOG NUMBER AND PRODUCT CODE. THE CATALOG NUMBER HAS BEEN UPDATED FROM CH00000001 TO CF 2893075 THAT WAS FOUND DURING THE COMPLAINT INVESTIGATION. THE PRODUCT CODE HAS BEING UPDATED FROM FSY TO KZF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SCREW BECAME DISCONNECTED AND THE LIGHT HEAD DROPPED FROM THE ARM IN L&D AND MADE CONTACT WITH A NURSES HEAD. THE NURSE REPORTEDLY RECEIVED TREATMENT FOR A CONCUSSION AND MISSED WORK FOR 4 DAYS. THERE WAS NO REPORTED ADVERSE CONSEQUENCES OR DELAYS TO PROCEDURE FOR THE PATIENT INVOLVED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT IN THE LABOR & DELIVERY ROOM, A SCREW BECAME DISCONNECTED AND THE F300 EXAM LIGHT DROPPED FROM THE ARM AND HIT CONTRACTED EMPLOYEE IN THE HEAD. A STRYKER FIELD SERVICE TECHNICIAN (SFST) WAS DISPATCHED FOR INVESTIGATION. DURING HIS ONSITE VISIT, THE SFST FOUND THAT THE AFFECTED UNIT WAS A ROLL STAND VERSION OF THE F300 EXAM LIGHT SYSTEM. ONSITE INVESTIGATION PHOTOS SHOWED THAT THE SCREW USED TO SECURE THE SPRING ARM TO THE ROLL STAND WAS MISSING. WITH REGARDS TO THE CONTRACT EMPLOYEE¿S INJURIES, IT WAS REPORTED THAT THE INDIVIDUAL RECEIVED MEDICAL TREATMENT IMMEDIATELY AFTER THE INCIDENT AND WAS DIAGNOSED WITH A CONCUSSION. THERE WERE NO CUTS OR LACERATIONS NOTED, BUT BRUISING WAS FOUND ON THE BACK OF THE NECK/HEAD AREA. THE CONTRACTOR REPORTEDLY MISSED 4 DAYS OF WORK AS A RESULT OF THE INCIDENT. ALTHOUGH THE EXACT ROOT CAUSE OF THIS ISSUE IS UNKNOWN, THE SFST NOTED THAT THIS EXAM LIGHT SYSTEM WAS LAST PM¿D/SERVICED BY THE HOSPITAL BIOMEDICAL TEAM IN JUNE 2018, AND THAT THE SYSTEM HAS BEEN IN USE FOR 14 MONTHS. THE MOST LIKELY ROOT CAUSE WOULD BE IMPROPER SERVICE AND MAINTENANCE BY HOSPITAL PERSONNEL AS OUTLINED IN THE CHROMOPHARE F300 EXAM LIGHT OPERATING MANUAL, PART #57363, REVISION J, SECTIONS 9.3 AND 9.4. THERE WAS NO REPORTED ADVERSE CONSEQUENCES OR DELAYS TO PROCEDURE FOR THE PATIENT INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW BECAME DISCONNECTED AND THE LIGHT HEAD DROPPED FROM THE ARM IN L&D AND MADE CONTACT WITH A NURSE'S HEAD. THE NURSE REPORTEDLY RECEIVED TREATMENT FOR A CONCUSSION AND MISSED WORK FOR 4 DAYS. THERE WAS NO REPORTED ADVERSE CONSEQUENCES OR DELAYS TO PROCEDURE FOR THE PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791312 MOBILE EXAMINATION LIGHT F 300, LED, DIMMABLE, W/EXTRA WEIGHT, 100-120 V(AC) W/S AC-POWERED MEDICAL EXAMINATION LIGHT KZF BERCHTOLD GMBH & CO. KG 07613327296167

    Patients

    Seq Age Sex Outcome Treatment
    1