BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11844665 · Received May 18, 2021

    Report

    Report Number
    2031642-2021-03754
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    May 6, 2021
    Product Code
    MNT
    UDI-DI
    00884838009851
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: (B)(6) 2021. G5: 510K: K102985. B4: (B)(6) 2021. THE FIELD SERVICE ENGINEER (FSE) INSPECTION WAS CARRIED OUT. THE FSE DID NOT MANAGE TO REPLICATE THE ERROR. THE FSE PERFORMED FULL PERFORMANCE ASSURANCE AND EXTENDED-SELF TESTING. ALL TESTS PASSED SUCCESSFULLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT SHUT DOWN. THE CUSTOMER REPORTED THAT THE UNIT WAS IN USE ON THE PATIENT, BUT NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739895 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 00884838009851

    Patients

    Seq Age Sex Outcome Treatment
    1