BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 4911585 · Received July 14, 2015

    Report

    Report Number
    2031642-2014-01352
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Report Date
    February 23, 2026
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP 1 REPORT HAS BEEN REQUESTED BY US FDA. UPON REVIEW OF THE CASE AND THE REPORTING ACTIVITIES COMPLETED, A COMPLETE INITIAL REPORT WITH ALL AVAILABLE INFORMATION WAS SUBMITTED SUCCESSFULLY ON 12/10/2024. NO FURTHER INFORMATION CAN BE ADDED. IF NEW INFORMATION IS RECEIVED REGARDING THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    THE INTERNATIONAL CUSTOMER REPORTED THE BACKUP BATTERY DOES NOT WORK. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT. THE MANUFACTURER'S FIELD SERVICE ENGINEER EVALUATED THE UNIT WHILE ONSITE AND CONFIRMED THE REPORTED PROBLEM. THE MANUFACTURER'S FIELD SERVICE ENGINEER REPLACED THE 3RD GENERATION POWER SUPPLY TO ADDRESS THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410262 RESPIRONICS VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, LLC V200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown