BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 12112243 · Received July 2, 2021

    Report

    Report Number
    2031642-2021-04270
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Date of Event
    June 10, 2021
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G5:510(K)#: K102985. B4:18AUG2021. THE ISSUE WAS OBSERVED DURING PREVENTIVE MAINTENANCE TESTING BEFORE THERAPEUTIC APPLICATION; THE REPORTED ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT IN CLINICAL USE. NO PATIENT OR USER HARM WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TOUCHSCREEN TOP PART DOES NOT RESPOND TO TOUCH. THE DEVICE WAS NOT IN CLINICAL USE. NO PATIENT OR USER HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004748 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1