BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA EMG ET MONITORING KIT

    MDR report key: 5229166 · Received November 17, 2015

    Report

    Report Number
    5229166
    Event Type
    Malfunction
    Date Received
    November 17, 2015
    Date of Event
    August 4, 2014
    Report Date
    November 6, 2015
    Manufacturer
    NEUROVISION MEDICAL PRODUCTS, INC.
    Product Code
    ETN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEUROVISION MEDICAL PRODUCTS; COBRA MONITORING ET TUBE SIZE 6.0MM. DR TESTED THE BALLOON BEFORE USING IN THE PT'S INTUBATION. DR NOTED THAT THE BALLOON DID NOT INFLATE. HE THEN GAVE ME THE TUBE WITH THE PACKAGING TO BE SENT TO BIOMED. I THEN GAVE HIM A NEW 6.0 COBRA TUBE. PT NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760161 COBRA EMG ET MONITORING KIT STIMULATOR, NERVE ETN NEUROVISION MEDICAL PRODUCTS, INC. 6.0MM 061014B

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR