BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEV-100

    MDR report key: 343086 · Received July 20, 2001

    Report

    Report Number
    2518422-2001-00036
    Event Type
    Death
    Date Received
    July 20, 2001
    Date of Event
    June 15, 2001
    Report Date
    June 21, 2001
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BYT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM DISTRIBUTOR THAT A PATIENT HAD EXPIRED AFTER A POWER OUTAGE OCCURRED AT THEIR PLACE OF RESIDENCE. INFORMATION OBTAINED FROM RESPIRATORY THERAPIST IS AS FOLLOWS: THE PT RESIDED AT AN ASSISTED CARE FACILITY WHICH HAD SUFFERED FROM A POWER OUTAGE ON EVENT DATE AROUND 11:30PM. THE PATIENT WAS USING THE DEVICE AT THAT TIME. THE POWER OUTAGE CAUSED THE UNIT TO SHUT DOWN AND SOUND AN ALARM, JUST AS INTENDED. THE PT REPORTEDLY REFUSED TO EXIT THE NU-MO SUIT AND WANTED TO WAIT TILL POWER RETURNED. APPROXIMATELY 10-15 MINUTES HAD PASSED, THE POWER RETURNED BUT THE ELECTRICAL OUTLETS REPORTEDLY WOULD NOT WORK. THE NURSE LEFT THE ROOM TO NOTIFY THE MANAGER AND, IN THE MEANTIME, THE PATIENT'S SPOUSE REPORTED PT STOPPED BREATHING. CPR WAS INITIATED WITHOUT SUCCESS. THERE WERE NO ALLEGED COMPLAINTS WITH THE DEVICE AND RESPIRATORY THERAPIST FELT THE DEVICE RESPONDED APPROPRIATELY. THE PT REPORTEDLY SUFFERED FROM A MASSIVE HEART ATTACK. PER THE MANAGER AT THE DISTRIBUTOR, THE PT DID NOT USE THE DEVICE CONTINUOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33031 NEV-100 NEGATIVE PRESSURE EXTERNAL VENTILATOR BYT RESPIRONICS, INC. 12001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death NU-MO SUIT.