BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESQPOD CE

    MDR report key: 958271 · Received November 29, 2007

    Report

    Report Number
    3003477173-2007-00001
    Event Type
    Injury
    Date Received
    November 29, 2007
    Date of Event
    October 14, 2007
    Report Date
    November 29, 2007
    Manufacturer
    ADVANCED CIRCULATORY SYSTEMS, INC.
    Product Code
    BWF
    PMA / PMN Number
    K033401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED TO HOSPITAL IN CARDIAC ARREST AND INTUBATED. DURING INTUBATION THE RESQPOD WAS APPLIED TO THE ENDOTRACHEAL TUBE. APPROXIMATELY THREE DAYS LATER, THE PATIENT DEVELOPED RESPIRATORY DISTRESS AND A DIRECT LARYNGOSCOPY WAS PERFORMED WITH REMOVAL OF A PLASTIC FOREIGN BODY FROM THE PATIENTS LARYNX. THE FOREIGN BODY WAS IDENTIFIED AS THE 1" X 2" PLASTIC TAB USED ON THE RESQPOD TO PREVENT THE TIMING ASSIST LIGHTS FROM ACTUATING DURING DEVICE SHIPPING. THE REPORTING PARTY CONCLUDES THAT THE TAB FOUND ITS WAY INTO THE PATIENT DURING INTUBATION. NO FURTHER COMPLICATIONS WERE REPORTED AND NO ADDITIONAL INFORMATION WAS PROVIDED ON THIS EVENT. NEITHER THE DEVICE NOR TAB WAS RETURNED TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESQPOD CE CIRCULATORY ENHANCER BWF ADVANCED CIRCULATORY SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention