BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT STAR VENTILATOR

    MDR report key: 150062 · Received February 13, 1998

    Report

    Report Number
    2025525-1998-00006
    Event Type
    Malfunction
    Date Received
    February 13, 1998
    Report Date
    February 11, 1998
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED THAT DEVICE FAILED TO ALARM AFTER PT DISCONNECT AND THE VISUAL LED DISPLAY WAS THE ONLY INDICATOR OF A LOSS OF CIRCUIT PRESSURE. CUSTOMER STATED THAT THIS IS AN INTERMITTANT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT STAR VENTILATOR VENTILATOR CBK NELLCOR PURITAN BENNETT 200 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other