BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAT BLUE RESUSCITATION BAG

    MDR report key: 1106 · Received August 18, 1992

    Report

    Report Number
    1106
    Event Type
    Death
    Date Received
    August 18, 1992
    Date of Event
    July 3, 1992
    Report Date
    July 12, 1992
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    BTC
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    88 YEAR OLD FEMALE IN ICU AND CRITICALLY ILL. SHE HAD A SWAN GANZ CATHETER INSERTED JUST PRIOR TO SUSTAINING A CARDIOPULMONARY ARREST. CPR WAS INITIATED AND SHE WAS INTUBATED AFTER SEVERAL ATTEMPTS. SHE WS FOUND TO HAVE BILATERAL PNEUMOTHOACES ON CXR. IT WAS NOTED THAT THE BALL VALVE OF THE EMBU BAG WAS NOT RELEASING TO PROVIDE FOR EXHALATION DURING THE RESUSITATION EFFORTS. THE RESUSCITATION EFFORTS WERE NOT EFFECTIVE. THE EQUIPMENT WAS NOT SAVED FOR FURTHER EVALUATION.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED PERMANENTLY, USER EDUCATION PROVIDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT BLUE RESUSCITATION BAG AMBU BAG BTC VITAL SIGNS, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death