BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESUS NEO MANOMETER AND MASK

    MDR report key: 16569559 · Received March 18, 2023

    Report

    Report Number
    3011137372-2023-00059
    Event Type
    Malfunction
    Date Received
    March 18, 2023
    Date of Event
    September 1, 2022
    Report Date
    February 21, 2023
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTM
    PMA / PMN Number
    K964719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE MANUFACTURING SITE, GALEMED, COMPLETED THE INSPECTION AFTER RECEIVING THE RETURNED SAMPLE ON 21 MAR 2023. THE ACTIONS TAKEN WERE AS FOLLOWS: 1. THERE ARE NO RELATED ABNORMAL PRODUCTION, INCOMING, AND INSPECTION RECORDS ABOUT LOT 191007 AND LOT 200824. 2. APPEARANCE INSPECTION OF CUSTOMER RETURN SAMPLES: APPEARANCE OF THE TWO RETURNED SAMPLES IS RELATIVELY IN A GOOD AND INTACT STATE, NOT BEEN SCRATCHED OR BROKEN. 3. AIR VOLUME TEST OF THE RETURN SAMPLES: VOLUME VALUE OF XTF0001 LOT 200824 AIR CUSHION MASK SAMPLE IS 2.15 (ACCEPTANCE RANGE 9.5-16.5MM). VOLUME VALUE OF XTF0101 LOT191007 IS 2.14 (ACCEPTANCE RANGE 8.3-13.3MM). SO, BOTH SAMPLES ARE INDEED UNQUALIFIED. A REVIEW OF THE AIR CUSHION MASK STANDARD MANUFACTURING PROCEDURE (SMP) WAS COMPLETED, AND IT COULD BE CONFIRMED THAT ALL AIR CUSHION MASKS WERE IN A GOOD STATE UPON PRODUCTION RELEASE. SINCE SAMPLE OF LOT191007 HAS EXCEEDED THE PERIOD OF VALIDITY DURING CLINICAL USAGE PERIOD, THERE IS A RISK FOR A LEAK. AND CONSIDERING THE MATERIAL OF RETURNED SAMPLES ARE PVC, FACTORS SUCH AS PRODUCTS SQUEEZING EACH OTHER HEAVILY AND UNCONTROLLED STORAGE AND TRANSPORT CONDITION, MAY LEAD TO AIR MOLECULES SPILLAGE AWAY THROUGH THE AIR CUSHION MASKS' SURFACE. FOR THESE REASONS, A ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    REPORTED ISSUE: THE CUFF WAS DEFLATED. THERE WERE NO CLINICAL CONSEQUENCES FOR PATIENTS.

    Description of Event or Problem · 0

    REPORTED ISSUE: THE CUFF WAS DEFLATED. THERE WERE NO CLINICAL CONSEQUENCES FOR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998511 RESUS NEO MANOMETER AND MASK VENTILATOR, EMERGENCY, MANUAL BTM TELEFLEX MEDICAL 200824

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NONE REPORTED| NONE REPORTED