BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESPIRONICS

    MDR report key: 12302013 · Received August 10, 2021

    Report

    Report Number
    2031642-2021-04523
    Event Type
    Death
    Date Received
    August 10, 2021
    Date of Event
    July 31, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT OUTCOME AND HEALTH IMPACT CODES WERE UPDATED BASED ON THE PREVIOUS INFORMATION SUBMITTED. CONCLUSION AND ROOT CAUSE CANNOT BE DETERMINED AS PER THE INSTITUTIONAL RISK MANAGER THE DEVICE REMAINS SEQUESTERED AND HAD NO ADDITIONAL INFORMATION THAT COULD BE PROVIDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE EVENT LOG WAS REVIEWED BY A THIRD-PARTY SERVICE ENGINEER (SE). THERE WERE NO EVENTS OR ALARMS RECORDED IN THE DEVICE LOG THAT INDICATE A DEVICE MALFUNCTION OCCURRED. THE CUSTOMER REPORTED ISSUE OF VENTILATOR TRANSITIONED TO STANDBY MODE WHILE IN USE COULD NOT BE CONFIRMED. THE VENTILATOR WAS RELEASED FROM SEQUESTRATION BASED ON THE SE EVALUATION. THE DEVICE WAS NOT RETURNED FOR FAILURE INVESTIGATION (FI). BASED ON THE SERVICE PERFORMED AND THE EVENT LOG REVIEW THE DEVICE MALFUNCTION ALLEGED BY THE CUSTOMER WAS NOT CONFIRMED. TRENDS FOR THIS TYPE OF ISSUE WILL CONTINUE TO BE MONITORED TO DETERMINE IF ADDITIONAL ACTIONS ARE REQUIRED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    FOLLOW-UP INFORMATION WAS RECEIVED FROM THE INSTITUTIONAL RISK MANAGER WHO INDICATED THAT THE VENTILATOR REMAINS SEQUESTERED, AND HAD NO ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATION HAS YIELDED THE FOLLOWING PATIENT INFORMATION: THE PATIENT WAS AN 85 YEAR OLD MALE (DO NOT RESUSCITATE/DO NOT INTUBATE) ADMITTED ON (B)(6) 2021 WITH VARIED DIAGNOSES OF CONFUSION, DIARRHEA, AND SIGNIFICANT CARDIOPULMONARY HISTORY INCLUDING MITRAL REGURGITATION AND PULMONARY HYPERTENSION. THE PATIENT WAS PRESCRIBED NON-INVASIVE BILEVEL VENTILATION VIA THE V60 DUE TO A DETERIORATION IN CONDITION WITH A NOTED PH DECREASE AND UNSPECIFIED ACIDOSIS. DURING THERAPY, THE PATIENT WAS REMOVED FROM THE DEVICE FOR ADMINISTRATION OF P.O.(PER OS) MEDICATION BY AN ATTENDING RN (REGISTERED NURSE). DURING THIS PERIOD THE DEVICE WAS PLACED INTO STANDBY MODE. AFTER ADMINISTRATION OF MEDICATION, THE PATIENT WAS PLACED BACK ONTO THE V60 VENTILATOR NON-INVASIVELY WHILE THE RN DISCUSSED PATIENT CARE WITH THE ATTENDING PA (PHYSICIANS ASSISTANT). THE NURSE RETURNED TO THE ROOM AND FOUND THE PATIENTS CONDITION HAD DETERIORATED FURTHER, NOTING THE DEVICE REMAINED IN STANDBY MODE. PATIENT VITALS WERE RECORDED AT 2200 (UNDISCLOSED SPO2). THE PATIENT WENT INTO ASYSTOLE AND PRONOUNCED AT 2216. PRELIMINARY INVESTIGATION OF THE DEVICE WAS CONDUCTED BY THE INSTITUTIONAL BIOMEDICAL ENGINEER. A DRPT (DIAGNOSTIC REPORT) WAS RETRIEVED AND FURNISHED TO PHILIPS FOR REVIEW WITH NO ERROR OR MALFUNCTION NOTED. THE CUSTOMER HAS ELECTED TO ENLIST THEIR OWN THIRD-PARTY BIOMEDICAL SERVICE OF THE DEVICE TO CONDUCT PVT (PERFORMANCE VERIFICATION TESTING). FURTHER INFORMATION AND EVALUATION RESULTS ARE PENDING.

    Additional Manufacturer Narrative · 1

    REPORT DATE: 10AUG2021. (B)(4).

    Description of Event or Problem · 1

    PHILIPS HAS BEEN NOTIFIED OF AN ALLEGED V60 VENTILATOR MALFUNCTION WHEREBY THE DEVICE IS CLAIMED TO HAVE ENTERED "STANDBY MODE" WHILE IN USE ON A PATIENT AND PROVIDING THERAPY. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT PROVIDING POSITIVE PRESSURE THERAPY TO THE PATIENT. DUE TO THE ALLEGED MALFUNCTION OF THE V60 VENTILATOR, THE PATIENT SUBSEQUENTLY EXPIRED. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200794 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Death