BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 12031972 · Received June 21, 2021

    Report

    Report Number
    2031642-2021-04134
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    June 9, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838009851
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B4:13AUG2021. THE DEVICE WAS RECEIVED BY THE PHILIPS BENCH REPAIR. AN EVALUATION WAS PERFORMED BY THE BENCH TECHNICIAN AND THE REPORTED ISSUE WAS CONFIRMED AND TRACED TO A FAULTY DATA ACQUISITION PRINTED CIRCUIT BOARD ASSEMBLY (DA PCBA). THE BENCH TECHNICIAN REPLACED THE DA PCBA TO RESOLVE THE REPORTED ISSUE. THE DEVICE PASSED PERFORMANCE VERIFICATION TESTING. NO PARTS WERE RETURNED FOR FAILURE INVESTIGATION; THEREFORE, THE ROOT CAUSE AT THE COMPONENT LEVEL COULD NOT BE DETERMINED. AN EVALUATION WILL BE PERFORMED IF THE REMOVED COMPONENT IS RECEIVED, AND AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DA PCBA WAS RETURNED FOR FAILURE INVESTIGATION. VISUAL INSPECTION OF THE DATA ACQUISITION (DA) PCBA REVEALED NO EVIDENCE OF DAMAGE OR CONTAMINATION. AFTER TESTING, IT WAS DETERMINED THAT THE COMPONENT FAILURE U6 CREATED THE ERROR CODE 110A. A SOLENOID VALVE FROM THE DEVICE WAS ALSO RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE SOLENOID VALVE REVEALED NO EVIDENCE OF DAMAGE OR CONTAMINATION. THE SOLENOID VALVE WAS TESTED, AND NO FAILURES WERE IDENTIFIED. UPON FURTHER REVIEW, IT WAS FOUND THAT THE REPORTED ISSUE WAS OBSERVED DURING TESTING. NO PATIENT WAS USING THE DEVICE WHEN THE FAILURE OCCURRED, AND THERE WAS NO DELAY TO PATIENT¿S TREATMENT AS A RESULT OF THE REPORTED ISSUE. BASED ON THIS INFORMATION, IT HAS BEEN CONCLUDED THAT THIS IS NOT A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(6) 2021. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAD A PROXIMAL PRESSURE FAILURE. THE DEVICE WAS NOT BEING USED ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932370 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838009851

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown