BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREENLITE DISP MTL MAC 4

    MDR report key: 10025071 · Received May 5, 2020

    Report

    Report Number
    8030121-2020-00082
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Date of Event
    April 17, 2020
    Report Date
    April 17, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTED DATA: SECTION D.4-LOT# CORRECTED TO 2002341. THE SAMPLE WAS RECEIVED AND RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. THE MANUFACTURING SITE REPORTS THAT "THE BLADE WAS WORKING PERFECTLY. LIGHT WAS GLOWING ENOUGH WITHOUT ANY FLICKERING. LIGHT WAS STABLE. WE HAVE DONE THE LIGHT TESTING OF BLADE WITH 3 DIFFERENT TYPES OF HANDLE AND NOTICED THAT BLADE IS WORKING WITH ALL HANDLES AND GLOWING PERFECTLY." THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THERE WAS NO ISSUE FOUND WITH THE RETURNED SAMPLE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE LIGHT FLICKERS DURING INTUBATION DESPITE HAVING NEW BATTERIES AND A HANDLE THAT IS OPERATIONAL. THE DEVICE WAS REPLACED WITH ANOTHER BLADE. NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE LIGHT FLICKERS DURING INTUBATION DESPITE HAVING NEW BATTERIES AND A HANDLE THAT IS OPERATIONAL. THE DEVICE WAS REPLACED WITH ANOTHER BLADE. NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488615 RUSCH GREENLITE DISP MTL MAC 4 LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL 2002341

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.