BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE

    MDR report key: 8218324 · Received January 4, 2019

    Report

    Report Number
    8030673-2019-00021
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Date of Event
    December 13, 2018
    Report Date
    December 13, 2018
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    OEV
    UDI-DI
    10885403171130
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, VYAIRE MEDICAL HAS NOT RECEIVED THE SAMPLE FOR INVESTIGATION. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AMBU BAGS FALLING APART DURING A CODE.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SAMPLE FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE AIRLIFE INFANT MANUAL RESUSCITATOR ARE FALLING APART DURING A CODE. THE CUSTOMER REPORTED AN ALTERNATIVE MANUAL RESUSCITATOR WAS FOUND AND USED. THE CUSTOMER REPORTED THERE IS NO PATIENT CONSEQUENCE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8690 AIRLIFE CARDIOPULMONARY RESUSCITATION AID KIT OEV VYAIRE MEDICAL 2K8040 0001143879 10885403171130

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention