BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL SIGNS® PRESSURE INFUSOR

    MDR report key: 13722921 · Received March 10, 2022

    Report

    Report Number
    3004050971-2022-00023
    Event Type
    Malfunction
    Date Received
    March 10, 2022
    Date of Event
    February 9, 2022
    Report Date
    February 10, 2022
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    KZD
    UDI-DI
    10817357021308
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION UPDATE: D9, G3, G6, H2, H3, H6 AND H10. RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS EVALUATED AND TESTED. VYAIRE MEDICAL WAS UNABLE TO CONFIRMED THE REPORTED ISSUE. BASED ON THE RESULTS OF THE LEAKAGE TEST INSTRUCTIONS MWI-51004353-AS-009/I (PRESSURE LEAKAGE TEST) AND MWI-51004353-AS-010/G (LEAKAGE TEST 3 HOURS), WE CAN GENERALLY DETERMINE IF THE LEAK OCCURRED DURING THE MANUFACTURING PROCESS. THE RETURN SAMPLE MET THE AIR LEAKAGE STANDARD. ACCORDING TO THE DHR, ALL UNITS WERE PRODUCED USING THE MCP-51004353-AS-001/F PRODUCTION FLOW. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE VITAL SIGNS® PRESSURE INFUSOR AIR OUTPUT IS DRAINING GRADUALLY. THE ISSUE OCCURRED DURING PATIENT-USE FOR 72 HOURS. AS OF THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT HARM WITH THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270165 VITAL SIGNS® PRESSURE INFUSOR INFUSOR, PRESSURE, FOR I.V. BAGS KZD VYAIRE MEDICAL VITAL SIGNS® PRESSURE INFUSOR 213782 10817357021308

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown