BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OHMEDA

    MDR report key: 2494113 · Received November 9, 2011

    Report

    Report Number
    1419185-2011-18268
    Event Type
    Malfunction
    Date Received
    November 9, 2011
    Date of Event
    October 30, 2011
    Report Date
    November 29, 2011
    Manufacturer
    OHIO MEDICAL CORPORATION
    Product Code
    CAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER NOTIFIED OHIO MEDICAL ABOUT THE PROBLEM AND PROVIDED THE INCIDENT REPORT VIA E-MAIL. AS THE CUSTOMER ONLY PROVIDED THE SERIAL NUMBER THAT THEY (THE CUSTOMER) HAD ASSIGNED TO UNIT, OHIO MEDICAL CONTACTED CUSTOMER IN AN ATTEMPT TO CAPTURE THE SERIAL NUMBER THAT THE UNIT HAD BEEN ASSIGNED BY OHIO MEDICAL DURING PRODUCTION. AFTER CONTACTING CUSTOMER, OHIO MEDICAL WAS INFORMED THAT AFTER THE UNIT HAD FAILED, IT WAS DISCARDED. THE CUSTOMER REPRESENTATIVE COMMUNICATED WITH THE RESPIRATORY THERAPIST WHO HAD DISPOSED OF UNIT IN AN ATTEMPT TO COLLECT MORE INFORMATION. THE RESPIRATORY THERAPIST INFORMED THE CONTACT THAT THE SUBJECT UNIT WAS DISPOSED DUE TO ITS AGE AND THAT THE UNIT HAD BEEN DROPPED PRIOR TO ITS FAILURE. IT IS BELIEVED THAT THE DROP WAS THE CAUSE OF THE FRACTURE IN THE FLOW TUBE ASSEMBLY OF THE FLOWMETER. NOTE: (B)(6) WAS CUSTOMER REPRESENTATIVE FOR THE ABOVE COMMUNICATION NARRATIVE.

    Description of Event or Problem · 1

    TITLE: XXXXX. EVENT DESC: DURING NORMAL NASAL CANNULA CHECK, FOUND NO BUBBLING IN THE HUMIDIFIER. CHECKED FLOWMETER, BALL AT LITER-PER-MINUTE; WHEN FLOW TURNED UP, BUBBLING INCREASED. THEN TRIED TO TURN FLOWMETER OFF; BALL WOULD NOT DECREASE TO ZERO. FOUND THAT FLOWMETER HAD SMALL CRACK IN THE FLOW TUBE ASSEMBLY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? NA. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA FLOWMETER, OXYGEN CAX OHIO MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other