BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11593198 · Received March 30, 2021

    Report

    Report Number
    2031642-2021-03185
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    March 11, 2021
    Product Code
    MNT
    UDI-DI
    00884838025776
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G5:510(K)#: K102985. B4:14JUL2021. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE AND CONFIRMED THE REPORTED PROBLEM. THE FSE RECALIBRATED THE TOUCHSCREEN TO RESOLVE THE REPORTED ISSUE. NO PARTS WERE REPLACED. THE DEVICE PASSED REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS AND WAS PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED INTO TECHNICAL SUPPORT (TS) REPORTING THAT THE DEVICE¿S SCREEN IS FAULTY. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486858 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 VENT, CHINA OPT: CFLEX, AVAPS 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1