BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11925006 · Received June 2, 2021

    Report

    Report Number
    2031642-2021-03936
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    May 5, 2021
    Report Date
    October 2, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THE DEVICE WAS IN USE ON A PATIENT. THE PATIENT WAS PLACED ON AN ALTERNATE VENT. THERE WAS NO PATIENT HARM NOTED. FOLLOWING THE EVALUATION OF THE DEVICE, THE FIELD SERVICE ENGINEER REPLACED THE BLOWER AND FLOW SENSOR ASSEMBLY TO RESOLVE THE PROBLEM. THE UNIT WAS THEN FUNCTIONALLY TESTED AND SUCCESSFULLY PASSED SPECIFIED TESTS. NO OTHER ABNORMALITY WAS OBSERVED.

    Additional Manufacturer Narrative · 0

    A GAS DELIVERY SYSTEM (GDS) ASSEMBLY WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE GDS ASSEMBLY REVEALED NO OBVIOUS DUST OR DEBRIS ON THE UNIT. FAILURE INVESTIGATION (FI) WAS PERFORMED, AND THE CUSTOMER COMPLAINT WAS VERIFIED. THE RETURNED BLOWER IS SEIZED AND WILL NOT DELIVER AIR. THE ROOT CAUSE IS FAILURE OF THE MOTOR SHAFT.

    Additional Manufacturer Narrative · 1

    DATE OF REPORT: 02JUN2021. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT IS ALARMING CHECK VENT BLOWER STALLED. THE CUSTOMER CONTACTED PRODUCT SUPPORT AND REQUESTED FOR SERVICE REPAIR. THE CUSTOMER REPORTED THAT THE UNIT WAS NOT IN USE ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822364 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown