BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    700 SERIES VENTILATOR

    MDR report key: 404534 · Received July 10, 2002

    Report

    Report Number
    8020893-2002-00168
    Event Type
    Malfunction
    Date Received
    July 10, 2002
    Report Date
    July 9, 2002
    Manufacturer
    NELLCOR PURITAN BENNETT IRE.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE VENTILATOR WENT SAFETY VALVE OPEN WHILE IN USE. THERE WAS NO PATIENT HARM OR CHANGE IN THERAPY. THE PURITAN BENNETT CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE ALLEGED EVENT. THE UNIT PASSED EXTENDED SELF TESTING. NO PARTS WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 700 SERIES VENTILATOR VOLUME MECHANICAL VENTILATOR CBK NELLCOR PURITAN BENNETT IRE. 740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN