BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON HUMID-VENT FILTER, PEDIATRIC

    MDR report key: 2142061 · Received May 24, 2011

    Report

    Report Number
    8040412-2011-00079
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    May 12, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MFR AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT AIR WOULD NOT CIRCULATE THROUGH THE FILTER. ALLEGED INCIDENT OCCURRED DURING PRE-CHECK. COMPLAINT INDICATES THAT THE FILTER WAS CONNECTED TO THE WYE WHICH WAS CONNECTED TO THE ANESTHESIA CIRCUIT WITH A BREATHING BAG. ONCE THE BREATHING BAG WAS INFLATED DURING THE TEST; IT WOULD NOT DEFLATE ONCE THE MACHINE WAS TURNED OFF. PATIENT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON HUMID-VENT FILTER, PEDIATRIC HUMID-VENT FILTER BTT TELEFLEX MEDICAL NA 201039

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK THE MANUFACTURER WAS NOT LISTED.| THE ANESTHESIA CIRCUIT WITH A BREATHING BAG WAS| CONNECTED TO THE #11012 HUMID-VENT PEDIATRIC, BUT