BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11632374 · Received April 8, 2021

    Report

    Report Number
    2031642-2021-03296
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 9, 2021
    Product Code
    MNT
    PMA / PMN Number
    K110083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G5:510(K)#:K110083 B4:(B)(6)2021 THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT. A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE REPORTED ISSUE WAS CONFIRMED AND TRACED TO A FAULTY BLOWER ASSEMBLY. THE FSE REPLACED THE BLOWER ASSEMBLY. THE DEVICE PASSED PERFORMANCE VERIFICATION TESTING AND WAS PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAD AN AIR VALVE LIFTOFF FAILURE. THE DEVICE WAS NOT BEING USED ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532286 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT ESPRIT VENTILATOR V1000

    Patients

    Seq Age Sex Outcome Treatment
    1