BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 3935136 · Received July 15, 2014

    Report

    Report Number
    2031642-2014-00678
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    June 20, 2014
    Manufacturer
    REPIRONICS CALIFORNIA INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR WAS NOT WORKING ON AC POWER AND THERE WAS NO MAINS POWER LED INDICATOR. THE CUSTOMER REPORTED THE VENTILATOR BACKUP BATTERY WOULD NOT CHARGE. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURERS SERVICE ENGINEER REPLACED THE POWER SUPPLY TO ADDRESS THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412345 V200 VENTILATOR VENTILATOR, CONTINUOUS CBK REPIRONICS CALIFORNIA INC V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1