BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 8950986 · Received August 30, 2019

    Report

    Report Number
    2031642-2019-07709
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Report Date
    June 11, 2018
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2018. DATE OF REPORT: 30AUG2019. THE CUSTOMER WAS ADVISED THAT WITH THE CIRCUIT CONNECTED THAT THE PRESSURE IS 149 CMHO2 AND WILL NOT ADJUST. THE CUSTOMER WAS ADVISED TO REMOVE EVERYTHING FORM THE INSPIRATORY PORT AND PLUG THE PORT. THE PRESSURE WHEN TO 165 CMH2O, IT APPEARS THAT THE CIRCUIT HAS A LEAK. THE CUSTOMER WAS ADVISED TO DISASSEMBLE THE PRESSURE RELIEF VALVE (PRV) AND ADJUST SO THAT THE GUIDE SCREW REST IN THE CHANEL ON THE PRV PLUNGER AND TIGHT CIRCUIT THE PRV SHOULD BE ABLE TO BE ADJUSTED. NO PARTS WERE REPLACED. THIS MDR HAS BEEN REASSESSED AS REPORTABLE AFTER A REQUEST FROM THE FDA ON MARCH 1, 2019 TO REVIEW COMPLAINTS FROM 29 NOV 2017 TO 29 NOV 2018. AS THIS HAS BEEN REASSESSED, IT WILL APPEAR TO BE A LATE MDR.

    Description of Event or Problem · 1

    CALLER REPORTS THAT INITIALLY THE EXTENDED SELF TEST (EST) WAS FAILING FOR THE PRESSURE RELIEF VALVE (PRV). WHILE TROUBLESHOOTING WITH PHILIPS TECHNICAL SUPPORT IT APPEARS THE CIRCUIT HAS A LEAK. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746405 V200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, INC V200

    Patients

    Seq Age Sex Outcome Treatment
    1