BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3940165 · Received March 21, 2014

    Report

    Report Number
    8020893-2014-00653
    Event Type
    Injury
    Date Received
    March 21, 2014
    Report Date
    February 19, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE BUT WAS UNABLE TO DUPLICATE THE ISSUE. THE DEVICE PASSED ALL CALIBRATIONS, SHORT SELF-TEST, EXTENDED SELF-TEST (EST) AND PERFORMANCE VERIFICATION TEST (PVT) ACCORDING TO MANUFACTURER SPECIFICATIONS. IN THE EVENT THAT ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED THAT AN 840 VENTILATOR EXPERIENCED CONSTANT HIGH PRESSURE ALARMS WHILE BEING USED ON A PATIENT. NO PATIENT INJURIES WERE REPORTED AS A RESULT OF THE EVENT. DURING A FOLLOW-UP, THE RESPIRATORY THERAPIST INFORMED THE MANUFACTURER THAT THE PATIENT HAS A RESPIRATORY CONDITION THAT CAUSES HIGH PRESSURE ALARMS. THE DATE OF THE EVENT IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168460 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention