BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEV 100

    MDR report key: 7763622 · Received August 8, 2018

    Report

    Report Number
    2518422-2018-01854
    Event Type
    Death
    Date Received
    August 8, 2018
    Date of Event
    July 29, 2018
    Report Date
    January 8, 2019
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BYT
    PMA / PMN Number
    K910947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THE MANUFACTURER RECEIVED INFORMATION INDICATING A PATIENT EXPIRED WHILE USING A NEGATIVE PRESSURE VENTILATOR DURING A POWER OUTAGE. THE NEV 100 VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN THE DEVICE WAS POWERED ON, IT OPERATED AS DESIGNED, BUT WAS ALARMING. THE DEVICE'S TIMING BELT REQUIRED ADJUSTMENT TO ADDRESS THE ALARM. NO OTHER ISSUES WHERE OBSERVED. THE NEV 100 DOES NOT HAVE AN INTERNAL BATTERY BACKUP IN THE EVENT OF A POWER FAILURE. THE NEV 100 WAS SUPPLIED TO THE PATIENT WITH A BACKUP GENERATOR. THE GENERATOR WAS NEVER INSTALLED AND WAS UNAVAILABLE WHEN THE POWER OUTAGE OCCURRED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION INDICATING A PATIENT EXPIRED WHILE USING A NEGATIVE PRESSURE VENTILATOR DURING A POWER OUTAGE. THE MANUFACTURER IS CURRENTLY INVESTIGATING THIS EVENT AND A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602713 NEV 100 VENTILATOR, EXTERNAL BODY, NEGATIVE PRESSURE, ADULT (CUIRASS) BYT RESPIRONICS INC. 12001

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death