BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON RESUS NEO MANOMETER AND MASK

    MDR report key: 15447418 · Received September 19, 2022

    Report

    Report Number
    3011137372-2022-00181
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    August 17, 2022
    Report Date
    August 25, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTM
    PMA / PMN Number
    K964719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE ANALYSIS RECEIVED FROM THE MANUFACTURING SITE (GALEMED) REPORTS: CHECK THE PRODUCTION INFORMATION OF THE CUSTOMER COMPLAINT BATCH (LOT# 201207 & 210215), THERE IS NO RELATED ABNORMAL RECORDS; THE CUSTOMER'S SAMPLE CANNOT BE SENT BACK DUE TO LOCAL CONTROL, AND THE PHOTOS PROVIDED ARE TOO VAGUE FOR MORE SPECIFIC ANALYSIS. ALL MASK MUST BE TEST THE LEAKAGE IN PRODUCE PROCESS. OBVIOUSLY, IF THE CRACK IS SO LARGE, IT CANNOT PASS THE LEAKAGE TEST; ACCORDING WITH THE INFORMATION SHARE BY CUSTOMER AND THE CONFIGURATION OF THE MATERIAL IN THE BOX DIDN'T CORRESPOND TO CRACKING SO LARGE WHEN THE PACKAGE IS OPENED. " IT WAS ALSO REPORTED, "WE SPECULATE THAT THE OPERATOR DID NOT USE THE CORRECT METHOD TO REMOVE BURRS FROM THE PRODUCT DURING THE MANUFACTURING PROCESS. AS A RESULT, THE WELDING STRENGTH OF THE PRODUCT AT THIS POSITION IS REDUCED. HOWEVER, THERE WAS NO IMMEDIATE CRACK IN THE PRODUCTION PROCESS, SO THE LEAK TEST IN THE PLANT WAS QUALIFIED. IN THE PROCESS OF TRANSPORTATION, THE PRODUCT MAY BE SUBJECTED TO LARGE VIBRATION OR IMPACT, RESULTING IN DETERIORATION OR DAMAGE OF THIS POSITION. GALEMED HAS REPORTED THAT CORRECTIVE ACTIONS HAVE BEEN TAKEN.

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "THE ISSUE WE FOUND WITH THE PREVIOUS STOCK WAS THAT THE MASK DEFLATES OVER TIME AND CANNOT BE RE-INFLATED THIS MAKES THE BAG UNUSABLE". THE ISSUE WAS DETECTED PRIOR TO USE ON A PATIENT DURING INSPECTION/FUNCTIONAL TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "THE ISSUE WE FOUND WITH THE PREVIOUS STOCK WAS THAT THE MASK DEFLATES OVER TIME AND CANNOT BE RE-INFLATED THIS MAKES THE BAG UNUSABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250158 HUDSON RESUS NEO MANOMETER AND MASK VENTILATOR, EMERGENCY, MANUAL BTM TELEFLEX MEDICAL 210412

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown