BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW HEATED INSUFFLATOR TUBING (5BX)

    MDR report key: 2842420 · Received October 22, 2012

    Report

    Report Number
    2936485-2012-00522
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 9, 2012
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HIF
    PMA / PMN Number
    K003792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FOREIGN OBJECT WAS INSIDE THE STERILE PACKAGING. FURTHER, THE UNIT WAS NOT EXPOSED TO ADVERSE ENVIRONMENTAL CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH FLOW HEATED INSUFFLATOR TUBING (5BX) HIF STRYKER ENDOSCOPY SAN JOSE 12188FE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK