BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMO SURE HIGH FLOW INSUFFLATOR W/ SIDNE (EU1)

    MDR report key: 1940250 · Received December 9, 2010

    Report

    Report Number
    2936485-2010-00916
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 25, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HIF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT SUFFERED FIRST AND SECOND DEGREE BURNS. NO FURTHER INFO WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUMO SURE HIGH FLOW INSUFFLATOR W/ SIDNE (EU1) INSUFFLATOR HIF STRYKER ENDOSCOPY SAN JOSE 0911CE186

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK