BEUDAMED
    FDA Adverse Event Death Summary report: N

    BREATHING BAG

    MDR report key: 354674 · Received September 28, 2001

    Report

    Report Number
    1824226-2001-00001
    Event Type
    Death
    Date Received
    September 28, 2001
    Report Date
    September 28, 2001
    Manufacturer
    KING SYSTEMS CORP.
    Product Code
    BTC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN VERBALLY REPORTED TO KING SYSTEMS OF A PT DEATH AT HOSP, WHERE KING SYSTEMS BREATHING CIRCUITS AND BREATHING BAGS ARE USED. THE INCIDENT, INVOLVING A PT, WAS DESCRIBED AS A TRAUMA CASE. THE PT WAS REPORTEDLY ON "HIGH VENTILATORY PRESSURES". STAFF INVOLVED WITH THE CASE INDICATED THAT THEY HEARD A "POP". THEY CHECKED THE BREATHING BAG, AND REPORTED THAT THERE WAS A "HOLE IN IT". THEY THEN TRIED USING TWO ADD'L BREATHING BAGS ON THE EQUIPMENT WITH THE SAME RESULTS. THE BREATHING BAGS ALLEGEDLY INVOLVED IN THE INCIDENT WERE NOT RETAINED. HOWEVER, A SAMPLE WITH THE SAME LOT NUMBER AND PRODUCT CODE WAS SENT FROM THE FACILITY TO KING SYSTEMS FOR TESTING. TEST RESULTS INDICATED NO DEFECTS. THE FACILITY SPOKESPERSON DID NOT ATTRIBUTE THE DEATH TO THE KING SYSTEMS BREATHING BAG(S). NO ADD'L PT OR PRODUCT INFO HAS BEEN SUPPLIED TO KING SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43954 BREATHING BAG RESERVIOR BAG BTC KING SYSTEMS CORP. NA 13WU9

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death