BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7200 SERIES MICROPROCESSOR VENTILAT

    MDR report key: 135079 · Received November 24, 1997

    Report

    Report Number
    2024500-1997-00323
    Event Type
    Injury
    Date Received
    November 24, 1997
    Date of Event
    October 8, 1996
    Report Date
    November 10, 1997
    Manufacturer
    PURITAN BENNETT
    Product Code
    CBK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT ON OR ABOUT 10/08/1997, A PT WHO HAD UNDERGONE ESOPHAGOGASTRODUODENOSCOPY, SUFFERED AN ARREST AND THAT THE VENTILATOR AND/OR THE VENTILATOR ALARM SYS MALFUNCTIONED IN THAT THE ALARM SHOULD HAVE GONE OFF, NOTIFYING THE HOSP PERSONNEL OF THE PT'S CONDITION. THERE IS NO FURTHER INFO AVAILABLE REGARDING EITHER THE DEVICE, THE TESTING OF THE DEVICE OR THE PT CONDITION. 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 7200 SERIES MICROPROCESSOR VENTILAT VOLUME VENTILATOR CBK PURITAN BENNETT 7200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability