BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMO SURE XL HIGH FLOW INSUFFLATOR

    MDR report key: 2000647 · Received February 3, 2011

    Report

    Report Number
    2936485-2011-00071
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HIF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS READING THE WRONG PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUMO SURE XL HIGH FLOW INSUFFLATOR INSUFFLATOR HIF STRYKER ENDOSCOPY SAN JOSE 1010CE614

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK