BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESPIRONICS

    MDR report key: 13944310 · Received March 29, 2022

    Report

    Report Number
    2031642-2022-00782
    Event Type
    Death
    Date Received
    March 29, 2022
    Date of Event
    February 2, 2022
    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
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DIRECTOR OF RESPIRATORY THERAPY CONFIRMED THAT THE VENTILATOR ALARMS WERE SILENCED BY SOMEONE PRIOR TO THE RESPIRATORY THERAPIST ON DUTY ENTERING THE ROOM. THE THERAPIST NOTICED THE REMAINING TIME LEFT ON THE BANNER ALERT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING CLINICAL USE WITH V60 VENTILATOR, THE PATIENT¿S MASK CAME OFF AND THE UNIT DID NOT ALARM. THE PATIENT EXPIRED. A (B)(6)-YEAR-OLD MALE (WEIGHT: (B)(6) LBS.; HEIGHT: 6 FEET) WITH RELEVANT MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), CORONARY ARTERY BYPASS GRAFT (CABG) IN 2002, PACEMAKER PLACEMENT IN 2019, UNDIAGNOSED CARDIAC MURMURS, UNCOMPLICATED DIABETES MELLITUS, AND COVID-19 WAS PLACED ON V60 VENTILATOR (SOFTWARE VERSION 3.10) ON AN UNKNOWN DATE FOR AN UNSPECIFIED INDICATION. THE DEVICE CONFIGURATIONS INCLUDED A NON-INVASIVE (NIV) INTERFACE USING RESPIRONICS PERFORMA TRAK LARGE FULL FACE AND DISPOSABLE RESPIRONICS BIPAP SINGLE CIRCUIT (22 MM IN DIAMETER AND 6 FEET IN LENGTH), WITH PRESCRIPTIONS, SETTINGS AND ALARMS SET AT BIPAP S/T MODE; PS: 5; IPAP/PS 10; EPAP/PEEP 5; RATE 14; I-TIME 1.00 ; RISE 3; FIO2 40%; HIGH RATE 50; LOW RATE 10; HIGH PRESSURE 25; LOW PRESSURE 04, LOW VE 02, WITH UNDOCUMENTED HIGH VT AND LOW VT. ON (B)(6) 2022, AT 12:22, DURING CONFINEMENT IN A MEDICAL-SURGICAL UNIT, THE PATIENT WAS SEEN BY THE RESPIRATORY THERAPIST (RT) ON DUTY AND OBSERVED THAT THE DEVICE DISPLAYED A LOW TIDAL VOLUME. THE RT INCREASED THE FIO2 FROM 40% TO 60% AND SETTINGS WERE INCREASED TO 12/6. ON THE SAME DAY, WHEN A HOSPITAL STAFF CHECKED ON THE PATIENT, HE WAS FOUND TO HAVE EXPIRED. AT THE TIME OF DISCOVERY, THE PATIENT'S MASK HAD COME OFF AND WAS ON THE BEDSIDE FLOOR. THE CAUSE OF DEATH IS UNKNOWN. THE PATIENT'S LEVEL OF MENTATION PRECEDING THE EVENT WAS UNKNOWN. THE HOSPITAL STAFF STATED THAT THE DEVICE DID NOT GENERATE AUDIBLE ALARM AS AN ALERT THAT THE PATIENT HAD BEEN DISCONNECTED FROM THE UNIT. THE PATIENT WAS SEEN AGAIN BY THE SAME RT ON DUTY BEFORE THE TIME OF DEATH WAS CALLED AND NOTED THAT THE BIPAP HAD VISUAL ALARMS AND THE AUDIBLE ALARMS WERE SILENCED. THE DIRECTOR OF RESPIRATORY THERAPY CONFIRMED THAT THE BED ALARM WAS ON, AND A PULSE OXIMETER WAS IN PLACE. SHE ALSO REPORTED THAT THE ALARMS WERE SILENCED BY THE STAFF THAT WERE PRESENT BEFORE THE RT ON DUTY ENTERED THE ROOM. ON (B)(6) 2022, A FIELD SERVICE ENGINEER (FSE) CAME ON SITE TO CHECK THE DEVICE. HE INDICATED THAT THE INSTITUTIONAL BIOMED HAD REVIEWED THE LOG BEFORE HE CAME ON SITE. THE FSE DOWNLOADED THE DIAGNOSTIC REPORT (DRPT) AND FOUND NO ERRORS OR DEVICE RELATED ISSUES IN THE LOG. THERE WERE EPISODES OF PATIENT DISCONNECT (1200) ON THE DATE OF THE EVENT ((B)(6) 2022). THE FSE COMMUNICATED WITH THE CUSTOMERS OF SOME PATIENT DISCONNECT (1200) ON THE EVENT LOG, HOWEVER HE COULD NOT CONFIRM IF THERE WAS A PATIENT DISCONNECT ALARM LOGGED AROUND THE TIME WHEN THE PATIENT WAS FOUND AS HE WAS NOT INFORMED OF THE EXACT TIME OF DEATH. THE FSE RAN ALL TESTS AND A FULL PREVENTATIVE MAINTENANCE ON THE UNIT WAS PERFORMED AND PASSED ALL PERFORMANCE TESTS WITH NO ISSUES IDENTIFIED. ON (B)(6) 2022, THE FSE RETURNED TO THE SITE TO RUN THE DEVICE IN NORMAL VENTILATION, WITH SIMULATION OF PATIENT DISCONNECTS, RAN UNIT ON BATTERY AND PUT THE UNIT THROUGH ITS PACES ALL DAY. THE ALARM VOLUME CYCLED BETWEEN 1 AND 10. THE FSE RETURNED THE UNIT TO AC POWER AT 12:35 WITH NO INTERRUPTION OBSERVED IN THE UNIT. THE FSE PERFORMED ANOTHER PERFORMANCE VERIFICATION TEST (PVT) AND PASSED ALL TESTS, AND THE DEVICE WAS RETURNED TO CLINICAL USE. FULL FUNCTIONALITY AND PERFORMANCE VERIFICATION TESTS DID NOT IDENTIFY DEVICE RELATED ISSUES. THE FSE INFORMED THE INSTITUTIONAL BIOMEDICAL ENGINEER AND THE DIRECTOR OF RESPIRATORY THERAPY THAT THE UNIT DID NOT HAVE ANY ERRORS, FAULTS OR FAILURES IN THE UNIT LOG. THE DEVICE WAS RETURNED TO FULL CLINICAL USE. BASED UPON THE INFORMATION PROVIDED, NO DEVICE MALFUNCTION OR FAILURE TO PERFORM TO MANUFACTURER SPECIFICATIONS HAS BEEN FOUND. THE DEVICE WAS IN USE AT THE TIME OF THE EVENT. THE EXACT CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2900033 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death