BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11894714 · Received May 27, 2021

    Report

    Report Number
    2031642-2021-03855
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    April 27, 2021
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: (B)(6) 2021. G5: 510K: K102985. B4: (B)(6) 2021. THE FIELD SERVICE ENGINEER (FSE) ADVISED REPLACEMENT FOR THE DIM LIQUID CRYSTAL DISPLAY (LCD) AND CENTRAL PROCESSING UNIT (CPU) TRAY COVER.

    Additional Manufacturer Narrative · 0

    G5: 510(K)#: K102985. B4: (B)(6) 2021. THE CUSTOMER CONFIRMED THEY WERE EXPERIENCING A USER INTERFACE FAILURE AND THEY NEEDED TO REPLACE THE CENTRAL PROCESSING UNIT (CPU)TRAY COVER THAT WAS BROKEN. THE CUSTOMER REPLACED THE USER INTERFACE ASSEMBLY TO RESOLVE THE USER INTERFACE FAILURE; THE (CPU) TRAY WAS REPLACED TO RESOLVE THE ISSUE WITH THE (CPU) TRAY COVER. ALTHOUGH REQUESTED TO BE RETURNED, THE REMOVED COMPONENT WAS NOT RECEIVED FOR EVALUATION AT THIS TIME; THEREFORE, THE ROOT CAUSE AT THE COMPONENT LEVEL COULD NOT BE DETERMINED. AN EVALUATION WILL BE PERFORMED IF THE REMOVED COMPONENT IS RECEIVED, AND AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED EXPERIENCING ISSUES AND NEEDS PARTS. 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
    793392 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1