BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS BIPAP VISION

    MDR report key: 5115615 · Received October 1, 2015

    Report

    Report Number
    5115615
    Event Type
    Malfunction
    Date Received
    October 1, 2015
    Date of Event
    March 19, 2015
    Report Date
    September 30, 2015
    Manufacturer
    RESPIRONICS INC
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY CARE SERVICES WAS PAGED TO ASSESS PATIENT REQUIRING NON-INVASIVE VENTILATION(NIV). UPON ARRIVAL TO THE ED, IT WAS NOTED THAT THE PATIENT'S SPO2 WAS READING 66%. THE FIO2 WAS THEN INCREASED TO 1.0. THE PATIENT RESPONDED TO SETTING CHANGE WITH SPO2 INCREASED TO 95%. THE RT LEFT THE ROOM TO CHART FOR THE CHANGES MADE ON THE NIV. AT THAT TIME, PATIENT WAS ON CONTINUOUS VITAL SIGN MONITORING AND THE PRIMARY PHYSICIAN WAS AT BEDSIDE. WHILE THE RT WAS CHARTING, AN ALARM WAS HEARD COMING FROM THE ROOM. THE PRIMARY PHYSICIAN WHO WAS PRESENT IN THE ROOM WHEN THE ALARM WENT OFF, NOTIFIED THE RT. THE RT WENT INSIDE THE ROOM TO ADDRESS THE ALARM AND SAW THE NIV MACHINE WAS OFF AND THE VENT INOP WAS HIGHLIGHTED. THE NIV MACHINE WAS NOTED TO BE PLUGGED IN THE RED ELECTRICAL OUTLET WHEN THE MACHINE SHUT DOWN. THE PATIENT DID NOT HAVE ANY ADVERSE EFFECT DURING THE TIME OF THE INCIDENT. THE NIV MACHINE WAS RE-BOOTED AND VERIFIED TO BE OPERATING PROPERLY. THE UNIT WAS KEPT IN USE WITH RT AT THE BEDSIDE UNTIL A REPLACEMENT NIV UNIT WAS BROUGHT IN FOR THE PATIENT. THE PATIENT WAS TRANSITIONED TO THE NEW NIV UNIT WITHOUT INCIDENT. FOLLOW-UP CHECK AND DOCUMENTATION ON (B)(6)WAS COMPLETED BY THE RT. THE NIV UNIT IN QUESTION WAS REMOVED FROM SERVICE AND RED TAGGED. THE BIPAP MACHINE WAS A RENTAL UNIT FROM A THIRD PARTY VENDOR. THE RT NOTIFIED THE VENDOR AND THE VENDOR PICKED UP THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650965 RESPIRONICS BIPAP VISION VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE CBK RESPIRONICS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR