BEUDAMED
    FDA Adverse Event Death Summary report: N

    MCGRATH

    MDR report key: 5756065 · Received June 28, 2016

    Report

    Report Number
    3010244187-2016-00004
    Event Type
    Death
    Date Received
    June 28, 2016
    Date of Event
    June 1, 2016
    Report Date
    December 12, 2017
    Manufacturer
    MCGRATH
    Product Code
    CCW
    PMA / PMN Number
    K882433
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SERIAL NUMBER WILL BE REVIEWED TO DETERMINE THE DATE OF MANUFACTURE. PATIENT INFORMATION (ID, AGE, SEX, WEIGHT) AS WELL AS ADDITIONAL INFORMATION ASSOCIATED WITH THE COMPLAINT HAVE BEEN REQUESTED AND IS EITHER UNKNOWN, WILL NOT BE MADE AVAILABLE TO MEDTRONIC, OR WILL BE PROVIDED AND UPDATED IN A SUPPLEMENTAL REPORT. THE DEVICE IN THIS REPORT IS PRODUCT CODE: CCW, DEVICE CLASS: 1. REGULATION NUMBER: 868.5540 (510K EXEMPT).

    Additional Manufacturer Narrative · 1

    ONE MCGRATH LARYNGOSCOPE WAS INSPECTED PHYSICALLY AND FOUND NO DAMAGE. THE PRODUCT WAS THEN TESTED FOR PROPER OPERATION. NO FAULTS WERE FOUND. UNABLE TO CONFIRM CUSTOMER REPORTED FAULT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE, THE SCREEN DIDN'T TURN ON. ANOTHER BATTERY WAS INSTALLED BUT THE CONDITION DIDN'T CHANGE. THE DOCTOR TRIED TO USE THIS FOR AN URGENT PATIENT AND HE USED ANOTHER GENERAL LARYNGEAL SCOPE INSTEAD. IT WAS REPORTED THAT LATER AT AN UNSPECIFIED DATE AND TIME THE PATIENT DIED, AND THE DEATH WAS UNRELATED TO THIS DEVICE AND EVENT.

    Description of Event or Problem · 1

    PRIOR TO USE ON THE PATIENT, THE SCREEN DIDN'T TURN ON. ANOTHER BATTERY WAS INSTALLED BUT THE CONDITION DIDN'T CHANGE. THE DOCTOR TRIED THEN USED ANOTHER GENERAL LARYNGEAL SCOPE INSTEAD. IT WAS REPORTED THAT LATER AT AN UNSPECIFIED DATE AND TIME THE PATIENT DIED, AND THE DEATH WAS UNRELATED TO THIS DEVICE AND EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409603 MCGRATH LARYNGOSCOPE, RIGID CCW MCGRATH 300-000-000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention