BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 11739671 · Received April 28, 2021

    Report

    Report Number
    2031642-2021-03525
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    March 24, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DIAGNOSTIC REPORT ON 25-MAR-2021 AT 7:48 AM GENERATED 120E (LOW MINUTE VENTILATION) AND 120F(LOW TIDAL VOLUME), AND ANOTHER EPISODE OF 120F(LOW TIDAL VOLUME) AT 7:49 AM. A PHILIPS AUTHORIZED SERVICE REPRESENTATIVE PERFORMED A PERFORMANCE VERIFICATION TEST. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND MET FULL MANUFACTURER SPECIFICATIONS. IT WAS PLACED BACK INTO USE WITH THE CUSTOMER. PHILIPS WAS NOT ABLE TO CONFIRM THE REPORTED MALFUNCTION. BECAUSE THE PROBLEM COULD NOT BE RECREATED, THE CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    WHILE IN CLINICAL/THERAPEUTIC USE, THE V60 VENTILATOR WAS ALLEGED TO HAVE PROVIDED INCORRECT VOLUME DELIVERY (UNSPECIFIED) WITH NOTED FAILURE TO PROVIDE ALARM NOTIFICATIONS (UNSPECIFIED AUDIBLE OR VISUAL ALARM FAILURE). THE PATIENT WAS SUBSEQUENTLY REMOVED FROM THE MALFUNCTIONING VENTILATOR AND PLACED ONTO A BACKUP DEVICE (MAKE/MODEL UNSPECIFIED) WITH NOTED DESATURATION OF PERIPHERAL OXYGENATION (SPO2) TO AN UNSPECIFIED EXTENT. THE DEVICE WAS IN CLINICAL/THERAPEUTIC USE AT THE TIME OF THE ALLEGED EVENT. THE PATIENT WAS REMOVED FROM THE MALFUNCTIONING VENTILATOR AND PLACED ONTO A BACKUP DEVICE (MAKE/MODEL UNSPECIFIED). THE PATIENT EXPERIENCED NOTED DESATURATION OF PERIPHERAL OXYGENATION (SPO2) TO AN UNSPECIFIED EXTENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634921 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention