BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEONATAL RESPIRATORY HEATED WIRE CIRCUIT

    MDR report key: 125534 · Received October 6, 1997

    Report

    Report Number
    1718887-1997-00002
    Event Type
    Malfunction
    Date Received
    October 6, 1997
    Manufacturer
    MARQUEST MEDICAL PRODUCTS, INC.
    Product Code
    BZO
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OVER A PERIOD OF SEVEN DAYS THE CLINICIAN EXPERIENCED TWELVE 12 CIRCUITS WHICH OVERHEATED AND BECAME DEFORMED ON THE EXPIRATORY LIMB OF THE CIRCUIT. THE CIRCUITS WERE REPLACED WITH LIKE CIRCUITS AND MECHANICAL VENTILATION WAS RESUMED. THERE WAS NO PT INJURY RELATED TO THE MALFUNCTION. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE CIRCUITS REVEALED NO RELATED DISCREPANCIES. THE CLINICIANS HAVE USED THE HEATED WIRE CIRCUITS FOR MANY YRS AND ARE CONFIDENT WITH THE APPLICATION. THE USER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFO REGARDING FLOW RATED OR VENTILATOR PARAMETERS. NONE OF THE CIRCUITS WERE RETAINED FOR EVALUATION. WITHOUT ADDITIONAL INFO OR THE DISCREPANT CIRCUIT THE CAUSE FOR FAILURE CANNOT BE DETERMINED. FOLLOW UP PHONE CONVERSATIONS WITH THE CLINICIAN INDICATES NO FURTHER INCIDENTS HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEONATAL RESPIRATORY HEATED WIRE CIRCUIT HEATED WIRE RESPIRATORY CIRCUIT BZO MARQUEST MEDICAL PRODUCTS, INC. NA 101077

    Patients

    Seq Age Sex Outcome Treatment
    1 *