BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 12054071 · Received June 23, 2021

    Report

    Report Number
    2031642-2021-04176
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    June 1, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11:B5: THE CUSTOMER REPORTED THE NAVIGATION RING DOES NOT MOVE DURING PRE-VERIFICATION TESTING. H10: THE FRONT BEZEL WAS RECEIVED, AND IT WAS IDENTIFIED THAT PREVIOUS INVESTIGATIONS HAVE SHOWN LIQUID INGRESS IS DUE TO THE VARIABILITY OF THE ASSEMBLY PROCESS CAUSING THE REPORTED NAVIGATION RING FAILURE.

    Additional Manufacturer Narrative · 1

    REPORT DATE: 23JUN2021. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE NAV RING DOES NOT WORK. THERE WAS NO PATIENT INVOLVEMENT. THE FIELD SERVICE ENGINEER (FSE) DETERMINED THE FRONT BEZEL NEEDED TO BE REPLACED. THE FSE REPLACED THE FRONT BEZEL AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948944 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown