BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11625596 · Received April 6, 2021

    Report

    Report Number
    2031642-2021-03268
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 19, 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

    G4:21MAY2021. G5:510K: K102985. B4:17JUN2021. THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THE DEVICE WAS NOT IN CLINICAL USE. NO PATIENT OR USER HARM WAS REPORTED. THE FSE CONFIRMED THAT THERE WAS A STRONG NOISE WHEN THE VENTILATOR STARTED UP. THE FSE REPLACED THE TURBINE TO RESOLVE THE ISSUE. THE UNIT WAS TESTED, AND IT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VENTILATOR HAS A NOISE. THE UNIT WAS IN CLINICAL USE, BUT THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514663 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 VENT, CHINA OPT: CFLEX, AVAPS 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1