BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 12207528 · Received July 21, 2021

    Report

    Report Number
    2031642-2021-04387
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 24, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMOVED DATA ACQUISITION (DAQ) SYSTEM AND TWO SOLENOID VALVES WERE RETURN FOR ANALYSIS. VISUAL INSPECTION OF ALL RETURNED PARTS REVEALED NO EVIDENCE OF DAMAGE OR CONTAMINATION. A FAILURE INVESTIGATION (FI) WAS PERFORMED. THE SOLENOID VALVES WERE TESTED, AND NO FAILURES WERE IDENTIFIED. THE DATA ACQUISITION (DAQ) SYSTEM WAS INSTALLED IN THE FI TEST VENTILATOR TO ATTEMPT TO DUPLICATE THE REPORTED PROBLEM. THE CUSTOMER COMPLAINT WAS VERIFIED. THE ROOT CAUSE IS FAILURE OF PRESSURE SENSOR U7 ON DATA ACQUISITION (DAQ).

    Additional Manufacturer Narrative · 0

    THE AUTHORIZED SERVICE PROVIDER REPLACED SOLENOIDS 2 AND 4 AND THE DATA ACQUISITION (DA) BOARD. THE ISSUE IS RESOLVED.

    Additional Manufacturer Narrative · 1

    DATE OF REPORT: 21JUL2021. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING A CHECK VENT ERROR FOR PRESSURE SENSOR AUTOZERO FAILED. THERE WAS NO PATIENT OR USER INVOLVEMENT. THE REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE CUSTOMER AND CONFIRMED THE PRESENCE OF THE ERROR IN THE LOGS. THE RSE ADVISED THE CUSTOMER TO VERIFY PIN ALIGNMENT BETWEEN SOLENOIDS AND THE DATA ACQUISITION (DA) BOARD, REPLACE SOLENOID 2 AND 4, OR REPLACE THE DA BOARD. OTHER INFORMATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099416 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown