BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 4791962 · Received May 22, 2015

    Report

    Report Number
    2031642-2015-00937
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Report Date
    April 29, 2015
    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

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. PATIENT INFORMATION WAS REQUESTED AND HAS NOT BEEN PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE POWER SUPPLY IS NOT CHARGING THE BACKUP BATTERY. THE CUSTOMER REPORTED THERE WAS PATIENT INVOLVEMENT WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334821 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1