BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEONATAL CIRCUIT W/DUAL WATER TRAP

    MDR report key: 2922162 · Received January 15, 2013

    Report

    Report Number
    3004365956-2013-00013
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR (DEVICE HISTORY RECORD) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE DHR ALSO SHOWED THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECIFICATIONS. NO NON CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED DUE TO THE LACK OF PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION AN DETERMINE THE ROOT CAUSE.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE CIRCUIT WAS LEAKING AND FAILING THE SET-UP TEST ON THE VENTILATOR. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21536 HUDSON NEONATAL CIRCUIT W/DUAL WATER TRAP VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL 02H1100387

    Patients

    Seq Age Sex Outcome Treatment
    1 VIP VENTILATOR