BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7200A MICROPROCESSOR VENTILATOR

    MDR report key: 135586 · Received November 25, 1997

    Report

    Report Number
    2024500-1997-00327
    Event Type
    Malfunction
    Date Received
    November 25, 1997
    Date of Event
    October 29, 1997
    Report Date
    November 3, 1997
    Manufacturer
    PURITAN BENNETT CORP.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT COMPLAINT REPORT SHOWS THE CUSTOMER ALLEGED NO/INTERMITTENT AC ALARM AFTER HE COMPLETED A 10 K PM. THE CUSTOMER REPLACED THE HARNESS. THE CUSTOMER HAD DISCARDED THE PART THEREFORE NO INVESTIGATION CAN BE DONE. IT IS NOT VERIFIED THAT THE UNIT HAD NO/INTERMITTENT AC ALARM. AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY NELLCOR PURITAN-BENNETT THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7200A MICROPROCESSOR VENTILATOR VOLUME VENTILATOR CBK PURITAN BENNETT CORP. 7200A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *