BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 11611665 · Received April 2, 2021

    Report

    Report Number
    2031642-2021-03245
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    March 5, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B4:28JUL2021. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED; HOWEVER, THE DEVICE STOPPED, AND THE PATIENT WAS PROVIDED MEDICAL INTERVENTION, WHICH REQUIRED INTUBATION AND CODED (PATIENT WAS A CODE BLUE). THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE AND CONFIRMED THE REPORTED PROBLEM. THE FSE REPLACED THE BLOWER MOTOR PER THE INSTRUCTIONS IN CHAPTER 8, SECTION 8.30 OF THE V60 SERVICE MANUAL. PERFORMED 9.3.3 ELECTRICAL SAFETY (TEST 1), 9.3.4 LEAK TESTS (TEST 2), 9.3.6 PRESSURE ACCURACY (TEST 4), AND 9.3.7 AIR DELIVERY/FLOW ACCURACY (TEST 5) AS OUTLINED IN CHAPTER 9, SECTION 9.3. THE DEVICE PASSED THE REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER REPLACED THE MOTOR CONTROLLER PCBA AND BLOWER MOTOR. ELECTRICAL SAFETY TEST, LEAK TEST, PRESSURE ACCURACY TEST, AND AIR DELIVERY/FLOW ACCURACY TESTS WERE PERFORMED. THE DEVICE PASSED REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TECHNICAL SUPPORT (TS), REPORTING THAT THE DEVICE DISPLAYED BLOWER TEMPERATURE TOO HIGH DIAGNOSTIC ERROR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506035 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention