BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BCI 3303 HAND HELD PULSE OXIMETER

    MDR report key: 1460184 · Received June 30, 2009

    Report

    Report Number
    2182466-2009-00011
    Event Type
    Malfunction
    Date Received
    June 30, 2009
    Date of Event
    June 2, 2009
    Report Date
    June 29, 2009
    Manufacturer
    SMITHS MEDICAL PM, INC.
    Product Code
    DQA
    PMA / PMN Number
    K945754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS RETURNED TO THE SMITHS MEDICAL PM, INC. TECHNICAL SERVICE DEPARTMENT FOR EVALUATION. TECHNICAL SERVICE OBSERVED THE DEVICE HAD NO AUDIO. THE SPEAKER WAS PROVIDED TO MANUFACTURING ENGINEERING FOR EVALUATION. MANUFACTURING ENGINEERING NOTED THAT THERE WAS NO AUDIO OUTPUT BECAUSE THE VOICE COIL WAS OPEN. THE BLACK VINYL MATERIAL THAT HOLDS THE SPEAKER WIRES IN PLACE WAS REMOVED AND ONE OF THE WIRES WAS LOOSE AT THE CONNECTION TO THE CONTACT. THE VOICE COIL WIRES WERE EITHER NOT PROPERLY SOLDERED OR COULD POSSIBLY HAVE COME LOOSE WHEN THE CONNECTING WIRE WERE ATTACHED. THIS CONNECTION COULD HAVE BEEN BROKEN IF THE MONITOR WAS JARRED OR DROPPED HARD ENOUGH. (B)(4).

    Description of Event or Problem · 1

    BIOMEDICAL TECHNICIAN AT USER FACILITY ALLEGED THAT THE 3303 PULSE OXIMETER HAD AN INAUDIBLE ALARM. BIOMEDICAL TECHNICIAN ALLEGED THAT DURING AN ASSESSMENT INSPECTION OF THE PRODUCT, THE UNIT BEGAN WORKING FINE AND THEN IMMEDIATELY STOPPED ALARMING. THE BIOMEDICAL TECHNICIAN TRIED TO GET THE UNIT TO RE-ALARM, BUT HAD NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BCI 3303 HAND HELD PULSE OXIMETER PULSE OXIMETER WITH ALARMS DQA SMITHS MEDICAL PM, INC. 3303G

    Patients

    Seq Age Sex Outcome Treatment
    1