BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOLPHIN STD WTR RESIST HD

    MDR report key: 8670159 · Received June 5, 2019

    Report

    Report Number
    8030121-2019-00050
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Date of Event
    May 1, 2019
    Report Date
    May 15, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. 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. THE MANUFACTURER REPORTS "LIGHT TESTING TEST HAD BEEN PERFORMED ON PRODUCT AS PER FINAL INSPECTION CHECKLIST # FRM-001364 AND PRODUCT HAD QUALIFIED THE TEST. LIGHT WAS CONSTANT AND GLOWING ENOUGH WITHOUT FLICKERING. USER REPORTED FAILURE HAS NOT CONFIRMED. BLADE AND HANDLE BOTH WERE WORKING PERFECTLY TOGETHER. LIGHT WAS CONSTANT. USER ISSUE."

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: "INCIDENT HAPPENED IN THE EMERGENCY AMBULANCE. DURING AN INTERVENTION WHERE AN INTUBATION WAS NEEDED. ONCE THE BLADE SNAPPED ON THE HANDLE, THE LIGHT WAS BLINKING". ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT CONDITION.

    Additional Manufacturer Narrative · 1

    QN# (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: "INCIDENT HAPPENED IN THE EMERGENCY AMBULANCE. DURING AN INTERVENTION WHERE AN INTUBATION WAS NEEDED. ONCE THE BLADE SNAPPED ON THE HANDLE, THE LIGHT WAS BLINKING". ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463377 DOLPHIN STD WTR RESIST HD LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL 180701

    Patients

    Seq Age Sex Outcome Treatment
    1 LARYNGOSCOPE HANDLE