BEUDAMED
    FDA Adverse Event Summary report: N

    VISION BIPAP

    MDR report key: 1904416 · Received October 29, 2010

    Report

    Report Number
    1904416
    Date Received
    October 29, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 29, 2010
    Manufacturer
    PHILLIPS RESPIRONICS
    Product Code
    MNT
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    DURING TESTING OF THE EMERGENCY GENERATOR, TWO VISION BIPAP MACHINES IN THE ICU LOST POWER. THE MACHINES HAD BEEN PLUGGED INTO THE APPROPRIATE (RED) OUTLETS THAT HAVE EMERGENCY GENERATOR BACK UP. THERE WAS NO PATIENT INJURY BUT ONE PATIENT'S OXYGEN SATURATION LEVEL DROPPED TO 54%. THE PATIENT WAS NOT HARMED BECAUSE THE ICU NURSES IDENTIFIED AND RECTIFIED THE SITUATION IMMEDIATELY BY BAGGING THE PATIENT. THE ELECTRICAL ENGINEER STATED THAT, OTHER THAN THIS EVENT, THE TRANSFER FROM NORMAL TO EMERGENCY POWER WAS UNEVENTFUL - LASTING APPROXIMATELY ONE MILLISECOND. THE CLINICAL STAFF IN THE ICU STATED THAT THE TRANSFER LASTED LONGER THAN A MILLI SECOND - APPROXIMATELY 3 SECONDS. THE BIOMEDICAL ENGINEER TOOK BOTH VISION BIPAPS TO THEIR SHOP FOR INSPECTION. THEY WERE UNABLE TO DUPLICATE THE PROBLEM. THE BIOMEDICAL ENGINEER PLUGGED UNITS INTO AN ELECTRICAL OUTLET AND ATTACHED A TEST CIRCUIT TO TEST THE UNITS. PHILIPS RESPIRONICS TECHNICAL SUPPORT WAS CONTACTED TO VERIFY HOW THE UNIT SHOULD NORMALLY OPERATE. IT WAS STATED THAT PHILIPS RESPIRONICS DOES NOT VIEW THIS DEVICE AS A LIFE SUPPORT DEVICE. WHEN THE UNIT LOSES POWER FOR:1) LESS THAN 10 SECONDS: DURING POWER LOSS, THE UNIT WILL GIVE AN AUDIBLE ALARM AND THE "VENT INOP" LIGHT WILL LIGHT UP. WHEN POWER IS RESTORED, THE UNIT WILL START VENTILATING AUTOMATICALLY AT SETTINGS PRIOR TO POWER LOSS.2) MORE THAN 10 SECONDS: DURING POWER LOSS, UNIT WILL GIVE AUDIBLE ALARM AND "VENT INOP" LIGHT WILL LIGHT UP. WHEN POWER IS RESTORED UNIT WILL DEFAULT TO THE MAIN SCREEN, GIVE AN AUDIBLE ALARM, AND DISPLAY " AC POWER LOSS" ON THE DISPLAY. THE UNIT WILL NOT VENTILATE PATIENT IN THIS CONDITION (MONITOR BUTTON NEEDS TO BE SELECTED AND ALARM SILENCED). BOTH UNITS WERE TESTED UNDER BOTH CONDITIONS ABOVE AND UNITS OPERATED NORMALLY, AS STATED BY PHILIPS RESPIRONICS. BIOMEDICAL ENGINEER COULD FIND NO PROBLEM WITH THE UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISION BIPAP VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, BIPAP MNT PHILLIPS RESPIRONICS * *
    2 BIPAP VISION VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, BIPAP MNT PHILIPS RESPIRONICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR