BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 8421839 · Received March 14, 2019

    Report

    Report Number
    2031642-2019-01506
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Report Date
    February 19, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF REPORT : 15MAY2019, DATE REC¿D BY MFR : 20MAR2019. PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED UNIT FAILED THE PRESSURE RELIEF VALVE (PRV) TEST. FSE PERFORMED TROUBLESHOOTING AND WAS ABLE TO ADJUST THE PRV VALVE. AFTER THE PRV VALVE WAS ADJUSTED, THE UNIT PASSED THE PRV TEST. FSE PERFORMED THE REQUIRED TESTS AND ALL TEST PASSED. 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: 14MARCH2019. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PRESSURE RELIEF VALVE TEST FAILED. THERE WAS NO PATIENT OR USER HARM REPORTED. THE EVENT DATE WAS NOT SPECIFIED; ESTIMATE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216315 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1