BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7200AE MICROPROCESSOR VENTILATOR

    MDR report key: 323529 · Received March 29, 2001

    Report

    Report Number
    2024500-2001-00025
    Event Type
    Malfunction
    Date Received
    March 29, 2001
    Date of Event
    May 6, 1999
    Report Date
    March 27, 2001
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAX REPORT FROM FACILITY STATES, "VENTILATOR AUDIBLE ALARM WAS NOT WORKING. PT WAS CHANGED TO ANOTHER VENT. (ACCORDING TO FAMILY... THE 'MACHINE HAS BEEN VERY QUIET LATELY.')" AN ADDITIONAL FAX REPORT STATED, "VENTILATOR WAS CHANGED OUT WITHOUT COMPLICATIONS TO THE PT. THE VENTILATOR WORKED NORMALLY, EXCEPT FOR THE AUDIBLE ALARMS. VISUAL ALARMS WORKED PROPERLY." PER RISK MANAGEMENT, PT'S VITALS DID NOT CHANGE. IT IS DETERMINED WHAT ALARM PARAMETER WAS BELIEVED TO HAVE BEEN VIOLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13861 7200AE MICROPROCESSOR VENTILATOR VOLUME VENTILATOR CBK NELLCOR PURITAN BENNETT 7200AE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR