BEUDAMED
    FDA Adverse Event Injury Summary report: N

    40 LTR HIGH FLOW INSUFFLATOR (W/POWER CORD & VERES)

    MDR report key: 829795 · Received March 14, 2007

    Report

    Report Number
    2936485-2007-00018
    Event Type
    Injury
    Date Received
    March 14, 2007
    Date of Event
    February 16, 2007
    Report Date
    February 16, 2007
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT YET TO BE RETURNED. INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED IF ANY NEW INFO IS LEARNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD SOME POST OP SYMPTOMS OF SPIKED CO2 LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 40 LTR HIGH FLOW INSUFFLATOR (W/POWER CORD & VERES) INSUFFLATOR FCX STRYKER ENDOSCOPY SAN JOSE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention