BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNEUMO SURE XL HIGH FLOW INSUFFLATOR

    MDR report key: 2140260 · Received June 15, 2011

    Report

    Report Number
    2936485-2011-00428
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HIF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT INTO CARDIAC ARREST DURING THE CASE. IT WAS FURTHER REPORTED THAT THE CUSTOMER THOUGHT THE PRODUCT MAY BE TO BLAME FOR OVER PRESSURIZING THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening