BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEV100

    MDR report key: 548635 · Received April 8, 2004

    Report

    Report Number
    2518422-2004-00027
    Event Type
    Malfunction
    Date Received
    April 8, 2004
    Date of Event
    March 9, 2004
    Report Date
    March 9, 2004
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BYT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE UNIT WAS RETURNED FOR PREVENTATIVE MAINTENANCE WITH NO PROBLEMS IDENTIFIED. THE UNIT HAD NOT BEEN SERVICED BY RESPIRONICS SINCE 2000. DURING THE REPAIR EVAL IT WAS DISCOVERED THAT THE UNIT'S AUDIBLE ALARM WAS NOT FUNCTIONING. THE DISPLAY AND POWER BOARDS HAD BECOME LOOSE AND WERE RESEATED TO CORRECT THE PROBLEM. THERE WAS NO PT INVOLVEMENT OR REPORTED HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEV100 NEGATIVE PRESSURE EXTERNAL VENTILATOR BYT RESPIRONICS, INC. 12001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other