BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AIR CUSHION MASK,NEONATE

    MDR report key: 12537000 · Received September 27, 2021

    Report

    Report Number
    3011137372-2021-00248
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    July 20, 2020
    Report Date
    September 1, 2021
    Product Code
    BSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. THE MANUFACTURER REPORTS THAT THE MANUFACTURING AND INSPECTION RECORDS OF LOT#180618 WERE REVIEWED AND NO ISSUES RELATED TO THE REPORTED COMPLAINT WERE FOUND. THE MANUFACTURER ALSO REPORTS THAT "THE MASK IS MADE OF PVC MATERIAL THROUGH BLOW MOLDING, THE MOLECULAR WEIGHT AND THE MOLECULAR DENSITY OF THE MASK IS HIGH, THE CUSHION WILL DEFLATE NATURALLY AT THE SEALING JOINT AFTER LONG TERM STORAGE." WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. CORRECTED DATA: SECTION B.4.-DATE OF THIS REPORT CORRECTED TO (B)(6) 2021.

    Description of Event or Problem · 0

    IT WAS REPORTED: "EXTREMELY PREMATURE BABY OF 25 WEEKS OF GESTATION, LOW WEIGHT FOR THE GESTATIONAL AGE WITH NEWBORN RESPIRATORY DISTRESS SYNDROME NEEDED INTUBATION , AN AIR CUSHION MASK WAS REQUIRED, ALTERATION IN THE PRESSURE OF THE CUSHION FILLING (DEFLATION) WAS OBSERVED AND THE DOCTOR REQUESTED TO CHANGE THE MASK. PATIENT AGE: 0. PATIENT HEIGHT: 35CM. PATIENT WEIGHT: 0.725KG. ADDITIONAL INFORMATION RECEIVED INDICATES "THE INCIDENT HAPPENED LAST YEAR, INFORMATION ABOUT THE PATIENT WAS NOT PROVIDED. THE ISSUE IN THE PRODUCT WAS DETECTED PRIOR TO USE, SO THE DOCTOR JUST CHANGED THE MASK." NO PATIENT INJURY OR HARM REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED: "EXTREMELY PREMATURE BABY OF 25 WEEKS OF GESTATION, LOW WEIGHT FOR THE GESTATIONAL AGE WITH NEWBORN RESPIRATORY DISTRESS SYNDROME NEEDED INTUBATION , AN AIR CUSHION MASK WAS REQUIRED, ALTERATION IN THE PRESSURE OF THE CUSHION FILLING (DEFLATION) WAS OBSERVED AND THE DOCTOR REQUESTED TO CHANGE THE MASK. PATIENT AGE: (B)(6), PATIENT HEIGHT: 35CM, PATIENT WEIGHT: (B)(6)KG. ADDITIONAL INFORMATION RECEIVED INDICATES "THE INCIDENT HAPPENED LAST YEAR, INFORMATION ABOUT THE PATIENT WAS NOT PROVIDED. THE ISSUE IN THE PRODUCT WAS DETECTED PRIOR TO USE, SO THE DOCTOR JUST CHANGED THE MASK." NO PATIENT INJURY OR HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431007 HUDSON AIR CUSHION MASK,NEONATE ANESTHETIC GAS MASK BSJ 180618

    Patients

    Seq Age Sex Outcome Treatment
    1