BEUDAMED
    FDA Adverse Event Other Summary report: N

    DATEX-OHMEDA HMEF 500, DISPOSABLE

    MDR report key: 618592 · Received August 2, 2004

    Report

    Report Number
    9610105-2004-00010
    Event Type
    Other
    Date Received
    August 2, 2004
    Date of Event
    June 14, 2004
    Manufacturer
    INSTRUMENTARIUM CORP.
    Product Code
    CAH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SP02 READING DECREASED FROM PATIENT'S CHEST BUT NO BREATHING SOUNDS WERE HEARD. A DOCTOR CHECKED THE PATIENT'S AIRWAY BUT NO OBSTRUCTION WAS FOUND. A DOCTOR TRIED TO PROVIDE MECHANICAL VENTILATION WITH JACKSON-REES. JUST THEN, THE BREATHING SOUNDS WERE HEARD AND THE DOCTOR THEN TRIED TO PROVIDE MECHANICAL VENTILATION WITH THE VENTILATOR. JUST THEN, THE BREATHING SOUNDS WERE NOT HEARD AGAIN. A DOCTOR TRIED AGAIN TO PROVIDE MECHANICAL VENTILATION WITH JACKSON-REES. JUST THEN, THE BREATHING SOUNDS WERE HEARD. AS A RESULT, SOMETHING WAS THOUGHT TO BE WRONG WITH THE VENTILATOR, BUT NO FAILURE WAS FOUND. FINALLY, HMEF500 WAS REPLACED. JUST THEN, THE BREATHING SOUNDS WERE HEARD CORRECTLY. BUT NO FAILURE WAS FOUND IN THIS DEFECTIVE HMEF500 BY ITS LOOKS. THE USE OF HMEF IS NORMAL ACCORDING TO THE INSTRUCTIONS FOR USE. THIS TYPE OF FAILURE HAS NOT OCCURRED BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-OHMEDA HMEF 500, DISPOSABLE FILTER, BACTERIAL, BREATHING-CIRCUIT CAH INSTRUMENTARIUM CORP. NA 40048

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other