BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 9030479 · Received September 13, 2019

    Report

    Report Number
    2031642-2019-09075
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Report Date
    August 30, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2019. DATE OF REPORT: 13SEP2019. THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN CONFIRMED THE REPORTED TOUCHSCREEN ISSUE. THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN REPLACED THE MMI PCBA TO ADDRESS THE REPORTED PROBLEM. THE DEVICE WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A TOUCHSCREEN FAULT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826438 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1