BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 12037760 · Received June 21, 2021

    Report

    Report Number
    2031642-2021-04141
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 27, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHILIPS INTERNATIONAL FIELD SERVICE ENGINEER (FSE) REPLACED THE SENSOR PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THE UNIT WAS FUNCTIONALLY TESTED AND SUCCESSFULLY PASSED ALL TESTING. THE UNIT WAS RETURNED TO SERVICE. NO OTHER ANOMALY WAS REPORTED.

    Additional Manufacturer Narrative · 0

    G5:510(K)#:K102054. B4: (B)(6) 2021. THE FIELD SERVICE ENGINEER REPORTED THAT THE SUSPECTED ISSUE WAS WITH THE SENSOR PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THE UNIT IS IN PAID STATUS AND IS YET TO RECEIVE APPROVAL FOR THE PART. THIS MAY BE DUE TO THE V200 VENTILATOR NO LONGER BEING SUPPORTED BY PHILIPS AND BEING AN END OF LIFE (EOL) PRODUCT. THEREFORE, THE VENTILATOR HAS NOT BEEN RECERTIFIED TO RETURN TO SERVICE. NO OTHER ANOMALIES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT OR USER HARM REPORTED. THERE WAS NO DELAY TO PATIENT THERAPY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A VENTILATOR FAILED THE FLOW SENSOR CALIBRATION AND EXPERIENCED A 9009 ERROR CODE INDICATING A VENTILATOR INOP DURING DEVICE TESTING OUTSIDE OF CLINICAL USE. THE DEVICE WAS EVALUATED BY THE INTERNATIONAL PHILIPS FIELD SERVICE ENGINEER WHO CONFIRMED THE REPORTED ISSUE. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT OR USER HARM REPORTED. THERE WAS NO DELAY TO PATIENT THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933709 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown