BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESPIRONICS

    MDR report key: 12870364 · Received November 24, 2021

    Report

    Report Number
    2031642-2021-05609
    Event Type
    Death
    Date Received
    November 24, 2021
    Date of Event
    October 25, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION RECEIVED BY A PHILIPS REMOTE SERVICE ENGINEER (RSE) FROM THE CUSTOMER INDICATED THAT THE O2 SETUP DURING PATIENT TRANSPORT WAS THE NORMAL SETUP, WITH THE V60 DEVICE CONNECTED TO THE 02 CYLINDER. THE TYPE OF COMPRESSED GAS CYLINDER USED WAS A BOC MEDICAL, UN 1072 O2, WITH APPROXIMATE GROSS WEIGHT OF 3.5 KG, WHILE THE TYPE OF GAS CYLINDER REGULATOR USED WAS A CYLINDER FITTED WITH A SCHRADER TYPE VALVE. THE PATIENT'S DATE OF DEATH WAS ON (B)(6) 2021. THE CAUSE OF DEATH REMAINS UNKNOWN AND HAS BEEN REQUESTED FROM THE CORONER. THE PATIENT'S DAUGHTER ALLEGED THAT THE DEVICE CAUSED HER MOTHER¿S DEATH, HOWEVER BASED ON THE REPORT, THE CUSTOMER STATED THAT IT WAS THE PATIENT'S BREATHING, MINUTE VOLUME AND TIDAL VOLUME WHICH DROPPED, AND NOT THE 02 SUPPLY BEING DELIVERED TO THE DEVICE. BASED UPON THE INFORMATION PROVIDED, THE EXACT CAUSE OF DEATH REMAINS UNKNOWN. NO FURTHER INFORMATION AND CONFIRMATION RECEIVED FROM THE CORONER¿S OFFICE.

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION RECEIVED BY A PHILIPS FIELD SERVICE ENGINEER ON (B)(6) 2021 STATES THAT THE PATIENT INVOLVED IN THE EVENT SUBSEQUENTLY EXPIRED WHILE CONNECTED TO THE V60 VENTILATOR. INFORMATION REGARDING DATE OF EXPIRATION AND THE CAUSE OF PATIENT DEATH HAS NOT CURRENTLY BEEN DIVULGED TO PHILLIPS AND IS CURRENTLY PENDING FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2021 AT APPROXIMATELY 1600 DURING INTRA-FACILITY TRANSFER OF A PATIENT FROM THE EMERGENCY DEPARTMENT TO AN UNSPECIFIED WARD, IT WAS NOTED THAT THE PATIENT CONDITION HAD DETERIORATED TO AN UNSPECIFIED EXTENT DUE TO THE SUPPLIED OXYGEN HOSING BECOMING DISCONNECTED FROM THE VENTILATOR AND FAILING TO PROVIDE A VISUAL OR AUDIBLE ALARM OF THE DISCONNECTION. PATIENT PRESCRIPTION FOR 100% FIO2 WAS NOTED. THE DEVICE WAS PROVIDING THERAPY TO A CRITICALLY ILL PATIENT DURING THE EVENT IN QUESTION. THE PATIENT WAS CLEARED FOR TRANSFER FROM THE EMERGENCY DEPARTMENT WITH A SATURATION OF PERIPHERAL OXYGENATION > 85%. A NOTED DETERIORATION OF PATIENT CONDITION WAS STATED DURING THE ALLEGED EVENT. UPON TRANSFER TO UNSPECIFIED WARD, THE PATIENT WAS NOTED TO HAVE BEEN RECEIVED BY CLINICAL STAFF IN PERRI ARREST STATUS. FURTHER EXTENT OF PATIENT DETERIORATION IS PENDING INVESTIGATION. THE DEVICE HAS BEEN INVESTIGATED AND EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER. THE DIAGNOSTIC REPORTS HAVE BEEN RETRIEVED FOR REVIEW AND INVESTIGATION. REVIEW OF THE DIAGNOSTIC REPORT HAS FOUND THAT ON THE ALLEGED DATE OF EVENT ((B)(6) 2021) AT 1547 THE DEVICE WAS NOTED TO HAVE PROVIDED ALARMS FOR O2 UNAVAILABLE AND LOW O2 SUPPLY PRESSURE. DEVICE USE WAS CONTINUED FOR SEVERAL DAYS AFTER THE EVENT IN QUESTION. ON 19-NOV-2021 THE DEVICE WAS EVALUATED AND INVESTIGATED, WITH FULL PERFORMANCE VERIFICATION TESTING CONDUCTED. PERFORMANCE VERIFICATION TESTING OF THE DEVICE YIELDED NO FINDINGS OF FAULT OR MALFUNCTION OF THE DEVICE TO PERFORM TO MANUFACTURER DECLARED SPECIFICATIONS. THE DEVICE HAS SUBSEQUENTLY BEEN RETURNED TO FULL CLINICAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767199 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention