BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 8937354 · Received August 27, 2019

    Report

    Report Number
    2031642-2019-07397
    Event Type
    Malfunction
    Date Received
    August 27, 2019
    Report Date
    July 4, 2018
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2018. DATE OF REPORT: 08/27/2019. CONFIRMED REPORTED PROBLEM: LOW TIDAL VOLUME. EST TEST :FAIL 3125,3126. EXHALATION FLOW SENSOR DEFECTIVE. LED PWR STATUS NOT LIGHT . RP-OVERLAY,PWR STATUS, ENGLISH, V200 DEFECTIVE. DEVICE IS NOT RETURNED TO FUNCTIONALITY, WAIT PO FROM CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR HAD LOW TIDAL VOLUME, INACCURATE FLOW RATE, AND THE LIGHT EMITTING DIODE (LED) POWER STATUS DID NOT LIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727562 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1