BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEE VALVED W/STEM AND PORT 15MM ID BASE

    MDR report key: 6965081 · Received October 20, 2017

    Report

    Report Number
    8030673-2017-00372
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    September 22, 2017
    Report Date
    October 20, 2017
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    BZA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN CONFIRMED BY (B)(4) THAT THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR EVALUATION. ATTEMPTS HAVE BEEN MADE BY CUSTOMER ADVOCACY TO GAIN ADDITIONAL INFORMATION FROM THE CUSTOMER AND END USER REGARDING THE SITUATION REPORTED WITH THE DEVICE. IF A SAMPLE OR ANY ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE PART BROKE APART DURING PATIENT USE AND A PART LODGED IN THE CIRCUIT CAUSING THE PATIENT TO HAVE TO BE UNHOOKED FROM THE VENTILATOR AND PUT ON A RESUSCITATION BAG. CUSTOMER DOES NOT HAVE THE BROKEN PART OR THE LOT INFORMATION. THERE WAS NO PHYSICAL DAMAGE CAUSED TO THE CIRCUIT. THE CIRCUIT WAS NEW ON (B)(6) 2017 AT 0315. WHEN IN THE PART LODGED INTO THE CIRCUIT THE PATIENT HAD HIGH PEAK AIRWAY PRESSURES AND LOW VOLUME. RT AND RN BOTH BEDSIDE IMMEDIATE RESPONSE TO BAG THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744928 TEE VALVED W/STEM AND PORT 15MM ID BASE CONNECTOR, AIRWAY (EXTENSION) BZA VYAIRE MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1