BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRATION 7I

    MDR report key: 17567904 · Received August 17, 2023

    Report

    Report Number
    3006135941-2023-00017
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    July 13, 2023
    Report Date
    August 17, 2023
    Manufacturer
    EVENT MEDICAL LTD.
    Product Code
    CBK
    UDI-DI
    00860008873637
    PMA / PMN Number
    K130178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S DISPLAY TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO EVENT MEDICAL: IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE SCREEN OF THE VENTILATOR WENT BLACK. THE EQUIPMENT WAS VENTILATING AND WORKING ALL THE TIME, WITHOUT STOPPING VENTILATION,THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. THE THIRD PARTY SERVICE PERSONNEL REPLACED THE DEVICE'S DISPLAY WHICH CORRECTED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963313 INSPIRATION 7I INSPIRATION VENTILATOR SYSTEM CBK EVENT MEDICAL LTD. INSPIRATION 7I 00860008873637

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention