BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 15381311 · Received September 8, 2022

    Report

    Report Number
    2031642-2022-02338
    Event Type
    Injury
    Date Received
    September 8, 2022
    Date of Event
    June 27, 2020
    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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW OF THIS COMPLAINT. IT HAS BEEN IDENTIFIED THAT MFR REPORT#: 2031642-2020-02295 IS THE CORRECT REPORT AND IS THE PRIMARY COMPLAINT. MFR REPORT#: 2031642-2022-02338 HAS BEEN IDENTIFIED TO BE A DUPLICATE AND SHOULD BE NULLED.

    Description of Event or Problem · 0

    THIS REPORT WAS RECEIVED FROM HEALTH CANADA (REFERENCE NUMBER 924078) VIA THE CUSTOMER FEEDBACK FORM. THE CUSTOMER REPORTED THAT THE REGISTERED RESPIRATORY THERAPIST (RRT) WAS ASSISTING THE REGISTERED NURSE (RN) TO TRANSFER PATIENT FROM BED TO CHAIR WHILE PATIENT WAS WEARING BIPAP MASK. THE VENTILATOR SHUT DOWN UNEXPECTEDLY WITHOUT AN ALARM. THE CUSTOMER REPORTED THAT THE V60 DEVICE WAS IN CLINICAL USE ON THE PATIENT WHEN THE DEVICE SHUTDOWN. THE PATIENT STATED HE COULD NOT BREATH. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND REPLACED WITH OPTIFLOW NASAL PRONGS AT FLOW OF 60 LITERS PER MINUTE (LPM) FIO2 90% AND OXIMASK WITH O2 AT 15 LPM UNTIL THE PATIENT RECOVERED. THE REPORT ALSO INDICATED THAT HAD THE RRT AND RN NOT BEEN IN THE ROOM AT THE TIME OF THE INCIDENT, THE OUTCOME COULD HAVE BEEN WORSE. THE RRT IMMEDIATELY CHECKED FOR SOURCE OF PROBLEM NOTING THE VENT HAD SHUT DOWN, DISPLAY SCREEN WAS COMPLETELY BLACK WITH DISPLAY SHOWING BLOWER FAILURE. (RRT) IMMEDIATELY REMOVED PATIENTS BIPAP MASK AND REPLACED WITH OPTIFLOW NASAL PRONGS AT FLOW OF 60 LPM FIO2 90% AND OXIMASK WITH O2 AT 15 LPM UNTIL PATIENT RECOVERED. INCIDENT REPORT COMPLETED BY REGISTERED RESPIRATORY THERAPIST AND REGISTERED NURSE AND SUBMITTED TO MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123166 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention