BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITROGEN REGULATOR-COMPLETE WITH COUPLERS

    MDR report key: 3640432 · Received February 21, 2014

    Report

    Report Number
    2520274-2014-00770
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Report Date
    January 24, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HXZ
    PMA / PMN Number
    K971544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL COMMON DEVICE NAME HWE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. (B)(6). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4): THE INSPECTION OF THE DEVICE REVEALED THE DEVICE WAS RECEIVED WITH A LEAKY VALVE. THE REPORTED OBSERVATION IS DUE TO NORMAL WEAR OF THE DEVICE. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON 02APRIL2014.THE SERVICE HISTORY REVIEW WAS NOT AVAILABLE.(B)(4)

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE NITROGEN REGULATOR SAFETY VALVE WAS LEAKY POST-SURGICAL PROCEDURE. NO HARM WAS REPORTED. THIS IS REPORT 1 OF 1 FOR THIS EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110376 NITROGEN REGULATOR-COMPLETE WITH COUPLERS HXZ SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1