BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON HEATED-WIRE NEONATAL VENTILATOR CIRCUIT

    MDR report key: 2060987 · Received March 14, 2011

    Report

    Report Number
    3004365956-2011-00128
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    January 11, 2011
    Report Date
    February 14, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: DEVICE HISTORY RECORD (DHR) REVIEW PERFORMED. RESULTS: THE DHR REVIEW SHOWED THAT NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THE COMPLAINT. THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECIFICATIONS. THE VISUAL EXAM REVEALED THAT THE PRESSURE PORT CAP WAS CRACKED. THE REPORTED COMPLAINT WAS CONFIRMED. THE ROOT CAUSE IS LISTED AS 'SPECIFICATION NOT FOLLOWED PROPERLY.' CONCLUSIONS: CORRECTIVE ACTION HAS BEEN TAKEN.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CIRCUIT WAS UNABLE TO PASS THE LEAK TEST ON MACHINE. IT WAS NOTICED THAT THE CAP ON THE PORT AT THE WYE WAS CRACKED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON HEATED-WIRE NEONATAL VENTILATOR CIRCUIT NEONATAL VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL NA 02A1001830

    Patients

    Seq Age Sex Outcome Treatment
    1