BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT SINGLE-USE RESUSCITATOR + PRESSURE RELIEF + MASK

    MDR report key: 16245801 · Received January 26, 2023

    Report

    Report Number
    3006061749-2022-00029
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    August 16, 2021
    Report Date
    January 26, 2023
    Manufacturer
    FLEXICARE MEDICAL LTD
    Product Code
    BTM
    PMA / PMN Number
    K181583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS BEING REPORTED UNDER MDSAP REQUIREMENTS WHERE IF AN EVENT TAKES PLACE IN A MDSAP COUNTRY, AND THAT DEVICE IS SOLD IN THE USA THE EVENT SHOULD ALSO BE REPORTED TO THE FDA.

    Description of Event or Problem · 0

    EVENT DESCRIPTION AS GIVEN TO MANUFACTURER "THE NURSE OPENED THE PACK TO FIND NO MASK INCLUDED. THE PACK WAS SEALED AND OBVIOUSLY SENT TO US IN THIS STATE. GIVEN THE CRITICAL NATURE OF THE PRODUCT THRUST YOU CAN SEE THE SERIOUSNESS OF THIS QUALITY FAILURE". NO PATIENT HARMED REPORTED, ANOTHER ONE WAS USED FROM A DIFFERENT CRASH CART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395495 INFANT SINGLE-USE RESUSCITATOR + PRESSURE RELIEF + MASK INFANT SINGLE-USE RESUSCITATOR BTM FLEXICARE MEDICAL LTD 190102853

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown