BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 8380305 · Received February 28, 2019

    Report

    Report Number
    2031642-2019-01187
    Event Type
    Malfunction
    Date Received
    February 28, 2019
    Report Date
    February 5, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF REPORT : 13MAY2019, DATE REC¿D BY MFR : 06APR2019. PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED UNIT NOT WORKING ON BATTERY POWER. RESOLUTION AND DISPOSITION: THE (FSE) RESEATED THE VIDEO GRAPHIC ARRAY (VGA) AND CHECKED CABLES REPLACED BATTERY EXTERNAL AND POWER SUPPLY, UNIT PASSED ALL PERFORMANCE TESTS AND IS READY TO BE RETURNED TO SERVICE. 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

    DATE REC'D BY MFR: 26MAY2019. A POWER SUPPLY WAS RETURN FOR ANALYSIS. A VISUAL INSPECTIONS OF THE POWER SUPPLY REVEALED EVIDENCE OF ACCUMULATION OF DUST ON THE POWER SUPPLY. THE RETURNED POWER SUPPLY WAS INSTALLED INTO THE FAILURE INVESTIGATION (FI) TEST VENTILATOR AND THE FI TECHNICIAN ATTEMPTED TO DUPLICATE THE REPORTED FAILURE BATTERY WILL NOT CHARGE. THE POWER SUPPLY PASSED ALL TESTS ADMINISTERED BY THE FI TECHNICIAN. THE POWER SUPPLY WAS TESTED AND NO FAILURES WERE IDENTIFIED. 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 · 1

    DATE OF EVENT: (B)(6) 2019. DATE OF REPORT: 28FEB2019. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS BATTERY IS NOT HOLDING CHARGE. NO PATIENT/USER HARM REPORTED. EVENT DATE NOT SPECIFIED; ESTIMATE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170637 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1