BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLV 100

    MDR report key: 280950 · Received June 6, 2000

    Report

    Report Number
    2518422-2000-00014
    Event Type
    Malfunction
    Date Received
    June 6, 2000
    Date of Event
    July 27, 1999
    Report Date
    June 5, 2000
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR WAS RETURNED FOR REPAIR DUE TO THE COMPLAINT OF IT ALARMING WITH EVERY BREATH. THERE WAS NO PATIENT HARM. HOWEVER, IN THE REPAIR EVALUATION, IT WAS DISCOVERED THAT THE VENTILATOR WOUDL STOP AND NOT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLV 100 CONTINUOUS VENTILATOR CBK RESPIRONICS, INC. 35001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR