BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7200 SERIES MICROPROCESSOR VENTILA

    MDR report key: 197421 · Received November 13, 1998

    Report

    Report Number
    2024500-1998-00241
    Event Type
    Malfunction
    Date Received
    November 13, 1998
    Date of Event
    October 1, 1998
    Report Date
    November 10, 1998
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT COMPLAINT REPORT SHOWS THE CUSTOMER WHILE PERFORMING A ROUTINE MAINTENANCE ON THE VENTILATOR, ALLEGED THE AUDIBLE ALARM'S VOLUME WAS LOW. THE CUSTOMER REPLACED THE ALARM ASSEMBLY AND REPORTED THAT THE UNIT'S VOLUME IS SUFFICIENTLY AUDIBLE. THERE WAS NO PT INVOLVEMENT CONNECT WITH THIS EVENT. THIS REPORT IS NOT AN ADMISSION BY NELLCOR PURITAN-BENNETT THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT. 150 GLOVER AVE NORWALKCT06856219923790012199237900119~8/7/97-MEDWATCH REPORT NOT RECEIVED BY MFR. SUBMISSION OF INITIAL REPORT TO FDA BY MFG.0HP

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7200 SERIES MICROPROCESSOR VENTILA VOLUME VENTILATOR CBK NELLCOR PURITAN BENNETT 7200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *