BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 12910097 · Received December 1, 2021

    Report

    Report Number
    2031642-2021-05656
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    November 11, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS WERE MADE TO INVESTIGATE THE ALLEGED DEVICE MALFUNCTION, WITH NO RESPONSE RECEIVED FROM THE REPORTER. DUE TO ABSENCE OF FURTHER INFORMATION, AN EVALUATION COULD NOT BE CONDUCTED, AND THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    PHILIPS RESPIRONICS WAS NOTIFIED THAT ON SEVERAL OCCASIONS USE OF HIGH FLOW THERAPY (HFT) AT FLOW DELIVERY SETTINGS OF 80 L/MIN RESULTED IN SEVERAL OCCURRENCES OF THE 122D DIAGNOSTIC CODE (CANNOT REACH TARGET FLOW). FOUR SEPARATE DEVICES HAVE BEEN ALLEGED TO EXHIBIT THIS BEHAVIOR BY THE CUSTOMER WITH ONE DEVICE OCCURRENCE RESULTING IN A PATIENT DESATURATION OF PERIPHERAL OXYGENATION (SPO2) TO AN UNSPECIFIED EXTENT. THIS COMPLAINT RECORD SHALL CAPTURE THE EVENT OF DESATURATION OF THE PATIENT¿S BLOOD OXYGEN CONTENT AND ADDITIONAL COMPLAINTS SHALL BE CAPTURED WITHIN PHILIPS¿S COMPLAINT RECORD DATABASE. THE DEVICE WAS IN CLINICAL AND THERAPEUTIC USE AT THE TIME OF THE EVENT. PATIENT DEMOGRAPHICS AND DEIDENTIFIED DATA HAVE NOT BEEN DIVULGED BY THE CUSTOMER. DURING THE EVENT IN QUESTION, THE PATIENT EXPERIENCED A DESATURATION OF SPO2 TO AN UNSPECIFIED EXTENT. INTERVENTION AND/OR ACTIONS TAKEN BY THE CUSTOMER ARE PENDING FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809704 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention