BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V200 VENTILATOR

    MDR report key: 8217917 · Received January 4, 2019

    Report

    Report Number
    2032640-2019-00001
    Event Type
    Injury
    Date Received
    January 4, 2019
    Report Date
    December 15, 2018
    Manufacturer
    PHILIPS HEALTHCARE / INNER COOL
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2018. DATE OF REPORT: 04JAN2019. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE. THE SE COULD NOT DUPLICATE THE REPORTED ISSUE. THE SE PERFORMED TESTING AND ALL TEST PASSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR PRESSURE RELIEF VALVE TEST IS FAILING DURING EXTENDED SELF TEST (EST) NO PATIENT INVOLVEMENT. THE EVENT DATE WAS NOT SPECIFIED; ESTIMATE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9310 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK PHILIPS HEALTHCARE / INNER COOL V200

    Patients

    Seq Age Sex Outcome Treatment
    1