BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 3885125 · Received June 19, 2014

    Report

    Report Number
    2031642-2014-00517
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    May 22, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR BACKUP BATTERY WAS NOT WORKING. THE CUSTOMER REPORTED THE UNIT WAS RUNNING ON AC MAINS POWER. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. AN ESTIMATE WAS PROVIDED TO THE CUSTOMER FOR REPAIR. NO INFORMATION HAS BEEN RECEIVED REGARDING CUSTOMER APPROVAL.

    Description of Event or Problem · 1

    CUSTOMER DECLINED REPLACING BACKUP BATTERY. UNIT WAS NOT REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360698 V200 VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1