BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11566280 · Received March 24, 2021

    Report

    Report Number
    2031642-2021-03108
    Event Type
    Malfunction
    Date Received
    March 24, 2021
    Date of Event
    March 3, 2021
    Product Code
    MNT
    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. B4:10AUG2021. THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED FAILURE. THE FSE REPLACED THE BLOWER MOTOR ASSEMBLY(TURBINE) TO RESOLVE THE TURBINE NOISE SOUND ISSUE. THE UNIT WAS TESTED, AND IT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TURBINE HAS NOISE. THE DEVICE WAS NOT IN CLINICAL USE. NO PATIENT OR USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458609 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT V60 VENT, CHINA  OPT: NONE

    Patients

    Seq Age Sex Outcome Treatment
    1