BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPAP SYNCHRONY S/T

    MDR report key: 2954205 · Received February 6, 2007

    Report

    Report Number
    2518422-2007-00012
    Event Type
    Injury
    Date Received
    February 6, 2007
    Date of Event
    January 9, 2007
    Report Date
    January 17, 2007
    Manufacturer
    RESPIRONICS INC.
    Product Code
    MNS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SUBMITTED A SAMPLE OF THE HUDSON OXYGEN TUBING USED DURING THIS ALLEGED EVENT TO THE MFR. THE CUSTOMER REPORTED EVENT COULD NOT BE DUPLICATED DURING MFG TESTING OF A RESERVE SAMPLE DEVICE AND THE SUPPLIED TUBING.

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT ALLEGES OXYGEN TUBING ATTACHED TO THE DEVICE BECAME DISCONNECTED RESULTING IN A LOSS OF SUPPLEMENTAL OXYGEN DELIVERY ALLEGEDLY CONTRIBUTING TO OXYGEN DE-SATURATION IN THE PT USING THE DEVICE. THE DEVICE WAS REPORTEDLY BEING USED WITH A MFR RECOMMENDED OXYGEN VALVE TO DELIVER SIX LPM OF SUPPLEMENTAL OXYGEN TO THE PT. THE PT WAS REPORTED TO HAVE DE-SATURATED INTO THE 30'S OR 40'S. A PULSE-OXIMETER IN USE ON THE PT REPORTEDLY ALARMED TO ALERT THE CAREGIVER OF AN EVENT. AS A RESULT, THE PT WAS REPORTEDLY PLACED ON A HIGH FLOW OXYGEN MASK AND SATURATION LEVELS RETURNED TO NORMAL. THERE WAS NO REPORT OF PT HARM OR PERMANENT INJURY. THE DEVICE WAS PUT BACK INTO THE PT POPULATION AND A REQUEST TO HAVE THE DEVICE AND OXYGEN VALVE RETURNED FOR EVAL COULD NOT BE HONORED AS THE DEVICE CANNOT BE IDENTIFIED. LABELING FOR THE DEVICE STATES IT IS INTENDED FOR THE TREATMENT OF RESPIRATORY INSUFFICIENCY WITH PTS THAT HAVE THE ABILITY TO MAINTAIN ADEQUATE VENTILATION FOR SOME PERIOD, SUCH AS OVERNIGHT. IT APPEARS THE DEVICE MAY NOT HAVE BEEN APPROPRIATE FOR THE PT'S ABILITY TO MAINTAIN OXYGEN SATURATION ON THEIR OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPAP SYNCHRONY S/T NON CONTINUOUS VENTILATOR MNS RESPIRONICS INC. 1004304 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R OXYGEN VALVE| PULSE OXIMETER| SUPPLEMENTAL OXYGEN| HUDSON OXYGEN TUBING