BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CONCHA COLUMN SHELFPAK, PED PAR

    MDR report key: 4121034 · Received July 28, 2014

    Report

    Report Number
    1417411-2014-00051
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    May 5, 2014
    Report Date
    July 14, 2014
    Manufacturer
    TELEFELX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS RECEIVED BY THE MANUFACTURER, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE COLUMN DID NOT PASS THE LEAK TEST. THE ALLEGED INCIDENT OCCURRED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439799 HUDSON CONCHA COLUMN SHELFPAK, PED PAR COLUMN FOR HUMIDIFICATION BTT TELEFELX MEDICAL 02G1302204

    Patients

    Seq Age Sex Outcome Treatment
    1 PURITAN BENNETT AVEA VENTILATOR (MODEL, 840)| CIRCUIT