BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3012307300-2021-01636

    MDR report key: 11391055 · Received February 28, 2021

    Report

    Report Number
    3012307300-2021-01636
    Event Type
    Malfunction
    Date Received
    February 28, 2021
    Date of Event
    January 1, 2021
    Report Date
    March 1, 2021
    Product Code
    IYT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER, OTHER TEXT: ONE PRODUCT WAS RETURNED. DEFECTIVE COMPONENT (AIR CUSHION FACE MASK) RESULTS: AS A RESULT OF OBSERVING THE PRODUCT IT WAS CONFIRMED THAT THE CUSHION OF THE PRODUCT WAS DEFLATED.???? CONCLUSION: THE REPORTED EVENT WAS CONFIRMED. ROOT CAUSE: IT WAS DETERMINED THAT THE EVENT WAS CAUSED BY THE MANUFACTURING OF THE SUPPLIER. ACTIONS:? WE ISSUED SCAR TO THE SUPPLIER "KOO MEDICAL JAPAN", REQUESTING THEM TO INVESTIGATE THE EVENT LOTS AND IMPLEMENT IMPROVE ACTIONS.

    Description of Event or Problem · 1

    DURING A PRE-USE CHECK, THE CUSTOMER NOTICED AIR WAS INADEQUATELY PUT IN THE BREATHING MASK IN THE PRODUCT KIT. THIS EVENT IS OFTEN OBSERVED AND THE CUSTOMER HAVE TO INFLATE THE MASK EVERY TIME BEFORE USING IT, SPOILING THE USABILITY IN AN EMERGENCY. THE CUSTOMER REQUESTS US TO THOROUGHLY CHECK WHETHER THE BREATHING MASK IS SUFFICIENTLY INFLATED PRIOR TO KITTING. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287985 IYT

    Patients

    Seq Age Sex Outcome Treatment
    1