BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACT INSTRUMENTATION, INC.

    MDR report key: 539426 · Received August 12, 2004

    Report

    Report Number
    539426
    Event Type
    Malfunction
    Date Received
    August 12, 2004
    Date of Event
    August 5, 2004
    Report Date
    August 10, 2004
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    THE PT HAS SEVERAL MEDICAL PROBLEMS. THE PT WAS PUT ON THE VENT BY RESPIRATORY THERAPISTS IN THE BACK OF THE AMBULANCE. WHILE PT WAS ATTACHED TO VENT AN ALARM WENT OFF INSTRUCTING THE AMOUNT OF VOLUME DELIVERED DOES NOT EQUAL THE AMOUNT SET. FIFTEEN MINUTES INTO THE TRIP THE PT'S MENTAL STATUS BECAME ALTERED WHICH PRIOR TO DEPARTING THE PT WAS ALERT. PT STATED THEY WERE HOT. PT WAS THEN BAGGED TO CHECK OUT THE VENT AND CALL THE TRANSFERRING HOSP. THE HOSP WAS INFORMED OF THE PT'S CONDITION AND ADVISED THAT THE PT PROBABLY "VAGALED" OUT. WITH SOME EVALUATION OF THE PT THE MEDIC FOUND THAT THE O2 SUPPLY WAS DEPLETED. THE PT WAS THEN PUT ON THE PORTABLE O2 AND REMAINED HAVING THE SAME PROBLEM. THE PT WAS THEN BAGGED AND PT'S MENTAL STATUS AND SKIN COLOR IMPROVED. ABOUT 15 MINUTES THE PT'S BP DROPPED BUT ALL OTHER VITALS CHECKED OUT FINE. PT'S BP DROPPED MORE AND THE CLOSEST HOSP WAS CALLED TO ACCEPT THIS PT. PT CONDITION IMPROVED AND THE PT WAS RETURNED TO PT'S ORIGINAL DESTINATION WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACT INSTRUMENTATION, INC. MODEL 754 EAGLE VENT CBK IMPACT INSTRUMENTATION, INC. EAGLE VENT 754 *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other