BEUDAMED
    FDA Adverse Event Other Summary report: N

    BALLARD HMEF 1000 HEAT AND MOISTURE EXCHANGER FILTER

    MDR report key: 509031 · Received February 2, 2004

    Report

    Report Number
    3031042-2004-00009
    Event Type
    Other
    Date Received
    February 2, 2004
    Date of Event
    January 1, 2004
    Report Date
    January 14, 2004
    Manufacturer
    INSTRUMENTARIUM CORP.
    Product Code
    BYD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A CARE GIVER THAT THE SAMPLE PORT CAP OF THE HMEF (HEAT AND MOISTURE EXCHANGER FILTER) HAD COME OFF THE HMEF, AFTER THE PT HAD BEEN MOVED AROUND QUITE A BIT. NO ONE NOTICED THAT THE CAP HAD COME OFF. THE CARE GIVER DISCOVERED AN INCIDENT WHEN RETURNING TO THE PT'S ROOM, NOT FROM A VENTILATOR ALARM. VENTILATOR AIR WAS ESCAPING THROUGH THE SAMPLING PORT, WHICH HAD A MISSING CAP, AND THE PT WAS TURNING BLUE. THE CARE GIVER ALSO INDICATED THAT THE PT ALMOST DIED. NO ADDITIONAL PT PROBLEMS OR RESIDUAL EFFECTS WERE NOTED. BALLARD MEDICAL PRODUCTS HAS NO FIRST HAND KNOWLEDGE OF THE ALLEGATIONS, BUT IS RELAYING INFORMATION RECEIVED FROM OUTSIDE SOURCES PURSUANT TO FEDERAL REGULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALLARD HMEF 1000 HEAT AND MOISTURE EXCHANGER FILTER BREATHING CIRCUIT BACTERIAL FILTER BYD INSTRUMENTARIUM CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening