BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 7877471 · Received September 14, 2018

    Report

    Report Number
    2031642-2018-01864
    Event Type
    Malfunction
    Date Received
    September 14, 2018
    Report Date
    August 22, 2018
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2018. DATE OF REPORT: 14/SEP/2018. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE. THE SE REPLACED THE MAN-MACHINE INTERFACE (MMI) PRINTED CIRCUIT ASSEMBLY (PCBA).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WOULD NOT TURN ON. THERE WAS NO PATIENT INVOLVEMENT. THE EVENT DATE WAS NOT SPECIFIED; ESTIMATE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720469 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1