BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11586598 · Received March 29, 2021

    Report

    Report Number
    2031642-2021-03163
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    March 1, 2021
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4:(B)(6)2021. G5:510K: K102985. B4:(B)(6)2021. THE CUSTOMER CONFIRMED THE REPORTED FAILURE. THE CUSTOMER REPLACED THE GAS DELIVERY SYSTEM (GDS) TO RESOLVE THE ISSUE. THE UNIT WAS TESTED AND IT WAS RETURNED TO SERVICE.

    Additional Manufacturer Narrative · 0

    G5:510K: K102985 B4:19UL2021. THE GAS DELIVERY SYSTEM (GDS) WAS RETURNED TO MANUFACTURER TO FAILURE ANALYSIS. CUSTOMER COMPLAINT VERIFIED. ROOT CAUSE WAS FAILURE OF OXYGEN SENSOR, CAUSED BY U1 DRIFTING OUT OF CALIBRATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ALARM NO OXYGEN IS DETECTED. THE CUSTOMER IS REQUESTING ONSITE SERVICE. 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
    483880 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1