BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 14279798 · Received May 4, 2022

    Report

    Report Number
    2031642-2022-01171
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    April 12, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE EVENT LOG INDICATED THE PRESENCE OF DIAGNOSTIC CODES 122D (CANNOT REACH TARGET FLOW) AND 122F (PATIENT CIRCUIT OCCLUDED). A PHILIPS FIELD SERVICE ENGINEER (FSE) SPOKE WITH THE CUSTOMER AND THE INSTITUTIONAL TECHNICAL SUPPORT TO CONFIRM THE DRPTA LOG CODES INDICATE THE ISSUE IS ASSOCIATED WITH THE PENDING SOFTWARE REPAIR UPDATE. THE FSE IS SCHEDULED TO RETURN TO PERFORM COMPLETE TESTING AND VERIFICATION RUN (TVR). THE FIELD SERVICE ENGINEER (FSE) WAS NOT ABLE TO DUPLICATE THE PROBLEM. THE FSE RETRIEVED THE DRPTA AND CONFIRMED WITH REMOTE SUPPORT THAT THE ERROR CODES WERE ASSOCIATED WITH THE SOFTWARE UPDATE. THE FSE PERFORMED A PERFORMANCE VERIFICATION TEST WITH NO ERRORS IDENTIFIED. THE SYSTEM MET THE MANUFACTURER'S SPECIFICATIONS FOR THE PERFORMED SERVICE AND WAS RETURNED TO USE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE VENTILATOR STOPPED BLOWING AIR THROUGH THE CIRCUIT AND HIGH FLOW NASAL CANNULA (HFNC). NO ALARMS WERE NOTED AT THE TIME. THE PATIENT IS AN (B)(6) FEMALE PATIENT (BODY WEIGHT: (B)(6)) OF UNKNOWN MEDICAL HISTORY WHO WAS PRESCRIBED V60 VENTILATOR VIA CONTINUOUS HIGH FLOW THERAPY (HFT) WITH HFNC INTERFACE. WHILE THE DEVICE WAS IN CLINICAL USE, THE PATIENT HAD AN EPISODE OF DESATURATION. THE PATIENT WAS SEEN BY A RESPIRATORY THERAPIST AND WAS TRANSITIONED TO ANOTHER BACKUP VENTILATOR TO CONTINUE WITH HFT. THE INSTITUTIONAL BIOMEDICAL ENGINEER (BME) CHECKED THE DEVICE AFTER IT WAS REMOVED FROM THE PATIENT. THE BME ATTACHED THE FLOW/O2 ANALYZER TO VERIFY OUTPUT. THE "SIGNIFICANT EVENT LOG¿ WAS RETRIEVED AND FORWARDED TO A PHILIPS AUTHORIZED SERVICE PROVIDER (ASP) FOR FURTHER TROUBLESHOOTING. THE PARAMETERS INCLUDED HFT: 30LPM / 40% O2 AND ANALYZER: 28 LPM/ 40%O2 AT TIME OF TESTING. THE ASP WAS NOT ABLE TO DUPLICATE THE PROBLEM. THE ASP PERFORMED COMPLETE TESTING AND VERIFICATION WITH NO ERRORS. THE ASP ADVISED THE CUSTOMER THAT A SOFTWARE UPDATE IS CURRENTLY BEING WORKED ON THAT CAN BE IMPLEMENTED ON VENTILATORS WHEN IT IS RELEASED. THE RECORD WILL BE CLOSED AND WILL BE REOPENED WHEN THE SOFTWARE UPDATE BECOMES AVAILABLE. THE VENTILATOR PASSED TESTING AND VERIFICATION AND WAS RELEASED FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2243002 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 PLUS VENTILATOR, US

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention