BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 15764226 · Received November 9, 2022

    Report

    Report Number
    2031642-2022-02804
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    August 30, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE AND CONFIRMED THE REPORTED PROBLEM OF A TOUCHSCREEN FAILURE. A GOOD FAITH EFFORT (GFE) RESPONSE HAS REVEALED THAT THE DEVICE HAS BEEN REPAIRED, THE DEVICE PASSED THE REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS AND WAS RETURNED TO SERVICE. THE CUSTOMER HAS OPTED NOT TO RETURN THE FAULTY PARTS FOR FURTHER INVESTIGATION. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. H11: CORRECTED DATA DEVICE PROBLEM CODE DPR-DOI-06 ELECTRICAL/ELECTRONIC PROPERTY PROBLEM - DPR-DOI-06-21 - DEVICE SENSING PROBLEM - DPR-DOI-06-21-08 - FAILURE TO SENSE CORRECTED TO: DPR-HFI-02 - HUMAN-DEVICE INTERFACE PROBLEM - DPR-HFI-02-04 - INADEQUATE USER INTERFACE - DPR-HPI-02-04-01 - NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    (B)(6). THE MANUFACTURER STILL NEEDS TO COMPLETE THE INVESTIGATION OF THIS EVENT. AN UPDATED REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE SENSOR HAS A PROBLEM. THE DEVICE WAS IN CLINICAL USE WHEN THE ISSUE OCCURRED. THERE'S NO PATIENT/USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2954632 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 VENT, CHINA OPT: CFLEX, AVAPS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown