BEUDAMED
    FDA Adverse Event Other Summary report: N

    VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY USE

    MDR report key: 1971911 · Received January 14, 2011

    Report

    Report Number
    2518422-2011-00005
    Event Type
    Other
    Date Received
    January 14, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 16, 2010
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K982454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE DEVICE TO BE RETURNED TO THE MFR FOR EVAL WAS DENIED BY THE FACILITY. A FIELD SERVICE TECH WAS SENT TO THE FACILITY BY THE MFR. THE FACILITY REPORTED TO THE TECH, THE MASK AND TUBING USED WITH THE DEVICE WERE DISPOSED OF AFTER THE EVENT AND WAS NOT AVAILABLE FOR INSPECTION. THE DEVICE WAS TESTED AND WAS FOUND TO OPERATE AND ALARM AS DESIGNED. NO FAILURES, DEFICIENCIES, OR DEVICE MALFUNCTIONS WERE IDENTIFIED DURING TESTING OF THE BIPAP VISION. THE MFR CONCLUDES THE DEVICE IS OPERATING PER MFR'S DESIGN SPEC AND THAT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED TO THE MFR THAT A PT WAS USING A BIPAP VISION AND BECAME DISCONNECTED FROM THE DEVICE. THE CONDITION WAS DISCOVERED WHEN THE PT HAD A BRADYCARDIC EVENT THAT WAS DETECTED BY THE HOSPITAL STAFF. THE PT'S HEART RATE WAS IN THE 30'S AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED." THE PT WAS INTUBATED AND PLACED ON A VENTRICULAR. THE FACILITY REPORTED THAT A NURSE ADMINISTERED MEDICATION 30 MINUTES PRIOR TO THE REPORTED EVENT AND THE DEVICE WAS OPERATING PROPERLY, AND THE PT WAS FULLY CONNECTED TO THE VENTILATOR AT THAT TIME. LATER THAT MORNING, THE NURSE OBSERVED A BRADYCARDIC RHYTHM ON THE PT'S MONITOR AT THE NURSE'S STATION. WHEN THE NURSE RESPONDED, THE BIPAP TUBING WAS REPORTEDLY DISCONNECTED FROM THE PT'S MASK. THE FACILITY WAS UNABLE TO CONFIRM IF THE BIPAP VISION AUDIBLY ALARMED AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY USE BIPAP VISION VENTILATORY SUPPORT MNT RESPIRONICS, INC. 582059

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R RESPIRONICS TUBING| RESPIRONICS FULL FACEMASK