BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRONY

    MDR report key: 1751195 · Received June 14, 2010

    Report

    Report Number
    1751195
    Event Type
    Malfunction
    Date Received
    June 14, 2010
    Date of Event
    May 20, 2010
    Report Date
    June 14, 2010
    Manufacturer
    PHILIPS RESPIRONICS, INC
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    AROUND 03:30 TO 03:45, THERE WAS A POWER FAILURE. THE PATIENT WAS ON THE SYNCHRONY BIPAP MACHINE WITH A NASAL MASK. ALL LIGHTS WENT OUT AND THE BIPAP MACHINE STOPPED WORKING DESPITE THE FACT THAT IT WAS PLUGGED INTO A RED ELECTRICAL OUTLET. THE SYNCHRONY BIPAP MACHINE DOES NOT HAVE A BACKUP BATTERY. ALSO, THERE IS NO DISCONNECT ALARM WHEN THE POWER IS OUT. THE PATIENT WAS AWAKE AND BREATHING ON HER OWN. WE PLACED HER ON A NASAL CANNULA AND I BEGAN TROUBLE SHOOTING TO SEE HOW I COULD RESOLVE THE SITUATION. I CHANGED THE PLUG IN FOR THE BIPAP FROM A RED OUTLET TO A WHITE OUTLET AND WAS ABLE TO RESTART THE BIPAP. AFTER ABOUT 7 TO 10 MINUTES, ALL POWER CAME BACK ON. THE PATIENT IS ABLE TO BE OFF HER BIPAP MACHINE FOR SHORT PERIODS ON A NASAL CANNULA. SHE DID NOT BECOME DISTRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRONY VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS RESPIRONICS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR