BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEV 100

    MDR report key: 797681 · Received December 21, 2006

    Report

    Report Number
    2518422-2006-00108
    Event Type
    Death
    Date Received
    December 21, 2006
    Date of Event
    November 22, 2006
    Report Date
    November 30, 2006
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BYT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    H6: THE DEVICE IS QUARANTINED BY THE CORONER. A REQUEST TO HAVE THE DEVICE RETURNED TO THE MFR FOR EVAL WAS DENIED. THE DEVICE WILL BE EVALUATED BY AN INDEPENDENT THIRD PARTY. H6: NO EVAL HAS BEEN PERFORMED AT THIS TIME.

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT THE DEVICE ALLEGEDLY SHUT DOWN AND SOUNDED A BEEPING ALARM WHILE IN PT USE. THE PT WAS FOUND TO BE NON-RESPONSIVE BY THE CAREGIVER, WHO CALLED 911 AND THE PT WAS TRANSFERRED TO A HOSP WHERE HE LATER EXPIRED. ALLEGEDLY, THE AUDIBLE ALARM WAS NOT HEARD BY THE CAREGIVER. THE DURATION BETWEEN WHEN THE DEVICE ALLEGEDLY SHUT DOWN AND WHEN THE CAREGIVER ATTENDED TO THE PT IS UNK. AN AUTOPSY WAS PERFORMED, BUT THE RESULTS WERE NOT RELEASED UPON REQUEST. ALTHOUGH VENTILATOR DEPENDENT, THE PT USED THE DEVICE IN A NON-INVASIVE MANNER ONLY AT NIGHT. ANOTHER DEVICE WAS USED THROUGHOUT THE DAY. IT IS UNK IF ADD'L ALARMS WERE IN USE AT THE TIME OF THE EVENT. THE DEVICE IS IN THE POSSESSSION OF THE COUNTY CORONER AND A REQUEST TO HAVE THE DEVICE RETURNED TO THE MFR FOR EVAL WAS DENIED. THE DEVICE WILL BE EVALUATED BY AN INDEPENDENT THIRD PARTY. IF PERTINENT INFO BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death PNEUMOSUIT