BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11748935 · Received April 29, 2021

    Report

    Report Number
    2031642-2021-03563
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 2, 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

    G4:19MAY2021. G5:510K: K102985. B4:16JUN2021. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND FOUND IT FAILED TOUCHSCREEN CALIBRATION. THE SE REPLACED THE TOUCHSCREEN, AND THE UNIT WAS CHECKED OVERALL, CLEANED, FUNCTIONALLY TESTED, AND NO ABNORMALITY WAS CONFIRMED.

    Additional Manufacturer Narrative · 0

    UPON FURTHER INVESTIGATION, THE REPORTED ISSUE OCCURRED DURING TESTING. THEREFORE, THIS COMPLAINT NO LONGER MEETS REPORTABILITY REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR HAD A SCREEN FAULT. ADDITIONAL INFORMATION ABOUT THE EVENT HAS BEEN REQUESTED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642600 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 VENT, CHINA OPT: CFLEX, AVAPS 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1