BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 7292874 · Received February 23, 2018

    Report

    Report Number
    2031642-2018-00400
    Event Type
    Malfunction
    Date Received
    February 23, 2018
    Report Date
    January 29, 2018
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REPORTED FOR MAINTENANCE IS A BIPAP HARMONY,HOME USE RESPIRATION MACHINE SERIAL NUMBER IS (B)(4). THIS ISSUE WAS IDENTIFIED AS NOT MDR/MDV/HC. COMPLAINT DETERMINED NOT MDR REPORTABLE PER FOLLOWING RATIONALE: BIPAP HARMONY IS INTENDED FOR HOME USE SLEEP THERAPY. THE BIPAP HARMONY IS NOT INTENDED TO BE A LIFE-SUPPORT DEVICE. EVENT DETERMINED AS NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    CANNOT CONFIRM SERIAL NUMBER. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED /V200/STOP WORKING INTERMITTENTLY. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136189 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1