BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CONCHA NEPTUNE

    MDR report key: 3243112 · Received July 18, 2013

    Report

    Report Number
    3003898360-2013-00310
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. PER DHR (DEVICE HISTORY RECORD) REVIEW THE PRODUCT CONCHA NEPTUNE, SERIAL # (B)(4) WAS MANUFACTURED ON 12/15/2011. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. DOCUMENT REVIEW (FMEA) WAS CONDUCTED AND NO CHANGES WERE REQUIRED. THE COMPLAINT CAN NOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT UNIT WILL NOT POWER UP WHILE IN USE. NO REPORT OF A PATIENT INJURY OR DELAY IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335567 HUDSON CONCHA NEPTUNE HEATED HUMIDIFICATION DEVICE BTT TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1