BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11741533 · Received April 28, 2021

    Report

    Report Number
    2031642-2021-03537
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 30, 2021
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G5:510(K)#: K102985 . B4:19AUG2021. PER THE CUSTOMER'S RESPONSE, THE TOUCHSCREEN WAS NOT RESPONDING. NO FURTHER DETAILS WERE PROVIDED. THE TOUCHSCREEN WAS REPLACED TO RESOLVE THE REPORTED ISSUE. NO PARTS WERE AVAILABLE FOR RETURN TO FAILURE INVESTIGATION; THEREFORE, THE ROOT CAUSE AT THE COMPONENT LEVEL COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TOUCHSCREEN NEED TO BE REPLACED. THE UNIT WAS NOT IN USE, AND THERE WAS NO PATIENT OR USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636402 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1