BEUDAMED
    FDA Adverse Event Other Summary report: N

    BALLARD HMEF 1000 HEAT AND MOISTURE EXCHANGER FILTER

    MDR report key: 511545 · Received February 10, 2004

    Report

    Report Number
    9610105-2004-00004
    Event Type
    Other
    Date Received
    February 10, 2004
    Date of Event
    January 1, 2004
    Report Date
    January 14, 2004
    Manufacturer
    INSTRUMENTARIUM CORP./DATEX-OHEMDA DIVISION
    Product Code
    CAH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CO RECEIVED THE REPORT FROM BALLARD MEDICAL PRODUCTS ABOUT THIS EVENT. THE SAMPLE PORT CAP OF THE HMEF (HEAT AND MOSITURE EXCHANGER FILTER) HAD COME OFF OF THE HMEF, AFTER THE PATIENT 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 PATIENT'S ROOM, NOT FROM A VENTILATOR ALARM. VENTILATOR AIR WAS ESCAPING THROUGH THE SAMPLING PORT, WHICH HAD A MISSING CAP, AND THE PATIENT WAS TURNING BLUE. THE CARE GIVER ALSO INDICATED THAT THE PATIENT ALMOST DIED. NO ADDITIONAL PATIENT PROBLEMS OR RESIDUAL EFFECTS WERE NOTED. DATEX-OHMEDA FINLAND OR BALLARD MEDICAL PRODUCTS HAS NO FIRST HAND KNOWLEDGE OF THE ALLEGATIONS, BUT IS RELAYING INFO 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 CAH INSTRUMENTARIUM CORP./DATEX-OHEMDA DIVISION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening