BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 11829421 · Received May 14, 2021

    Report

    Report Number
    3012307300-2021-04385
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 16, 2021
    Report Date
    May 14, 2021
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL BREATHING/PORTEX MANUAL RESUSCITATION 1ST RESPONSE PEDIATRIC RESUSCITATORS PLV OPENS, WHEN CLOSING THE PLV IS MAKING LOUD NOISES AND LEAKING PRESSURE, DOESN'T SEEM TO BE SEALING. NO PATIENT ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721425 PORTEX MANUAL RESUSCITATION 1RST RESPONSE PEDIATRIC BTM 181203

    Patients

    Seq Age Sex Outcome Treatment
    1