BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11625267 · Received April 6, 2021

    Report

    Report Number
    2031642-2021-03271
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 7, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838033832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER INVESTIGATION AND REVIEW OF THE COMPLAINT, THE REPORTED ISSUE WAS OBSERVED DURING PRE-USE TESTING OF THE UNIT BY THE MEDICAL ENGINEER (ME) PRIOR TO PATIENT USE. THEREFORE, THIS COMPLAINT NO LONGER MEETS REPORTABILITY REQUIREMENTS.

    Description of Event or Problem · 1

    THE MANUFACTURER'S PRODUCT SUPPORT ENGINEER (PSE) FOUND THE UNIT'S ALARM LED FAILED. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE PSE CONFIRMED THE ISSUE OF ALARM LED FAILED. THE PSE ALSO FOUND THE UNIT'S OXYGEN CONCENTRATION TEST WAS OUT OF SPECIFICATION. THE PSE REPLACED THE UNIT'S POWER SWITCH OVERLAY TO RESOLVE THE REPORTED ISSUE OF ALARM LED FAILURE. THE PSE REPLACED THE UNIT'S FLOW SENSOR ASSEMBLY TO RESOLVE OXYGEN CONCENTRATION TEST SPECIFICATIONS OUT OF RANGE. THE UNIT PASSED REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519901 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+ 00884838033832

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown