RESPIRONICS
Report
- Report Number
- 2031642-2022-02009
- Event Type
- Death
- Date Received
- August 1, 2022
- Date of Event
- July 25, 2022
- Manufacturer
- RESPIRONICS CALIFORNIA, LLC
- Product Code
- MNT
- PMA / PMN Number
- K102985
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
(B)(6). FURTHER INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
UPON FURTHER REVIEW AND INVESTIGATION OF THIS CASE, BELOW DETAILS WERE VERIFIED: DURING CLINICAL AND THERAPEUTIC USE OF THE V60 VENTILATOR, IT IS ALLEGED THAT AN UNANTICIPATED PATIENT DISCONNECTION VIA THE NON-INVASIVE INTERFACE WAS NOTED WITH AN FAILURE OF REMOTE ALARM TRIGGERING RESULTING IN A DELAY TO RESPONSE AND PATIENT EXPIRATION. ON THE EVENING ON (B)(6) 2022, A 75 YEAR OLD MALE PATIENT WAS PLACED ONTO THE V60 VENTILATOR FOR NON-INVASIVE (NIV) RESPIRATORY SUPPORT. THE PATIENT MEDICAL HISTORY PROVIDED INCLUDED PREVIOUS DIAGNOSES OF ISCHEMIC HEART DISEASE, HYPERTENSION, ATRIAL FIBRILLATION (AF), DYSLIPIDEMIA, ASTHMA, ASBESTOS EXPOSURE, AND A HISTORY OF SMOKING. THE PATIENT WAS PROVIDED RESPIRATORY SUPPORT VIA CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) OF 6 CMH2O. DURING THE COURSE OF TREATMENT, CPAP PRESSURES WERE TITRATED BETWEEN 6-10 CMH2O. THE PATIENT CONDITION WAS NOTED TO HAVE ESCALATED AND TYPE 2 RESPIRATORY FAILURE WAS OBSERVED PROMPTING A MORE CONTROLLED METHOD OF VENTILATION TO BE APPLIED: MODE PRESSURE CONTROL, 24 CMH2O IPAP, 6 CMH2O EPAP, INSPIRATORY TIME 1.0 SECOND, RISE TIME SETTING 3, BACKUP RESPIRATORY RATE 4 BREATHES PER MINUTE, FRACTION OF INSPIRED OXYGEN (FIO2) 80%. IT WAS REPORTED THAT DURING THERAPY THE PATIENT NIV INTERFACE HAD POTENTIALLY BECOME PARTIALLY DISLODGED AND SUBSEQUENTLY EXPIRED ON (B)(6) 2022 BETWEEN THE HOURS OF 1700-1800 LOCAL TIME. DURING THE PATIENT DISCONNECTION, THE CUSTOMER REPORTS THAT NO REMOTE ALARM WAS ANNUNCIATED. THE MAKE/MODEL AND SETUP OF THE CENTRAL INSTITUTIONAL ALARM SYSTEM HAS NOT BEEN SPECIFIED. DEVICE INVESTIGATION AND EVALUATION WAS CONDUCTED YIELDING THE FOLLOWING: DEVICE BREATHING CIRCUIT CONFIGURATION AND ATTACHMENTS: BREATHING CIRCUIT - RESPIRONICS BIPAP VISION DISPOSABLE CIRCUIT (REF 582072), INTERSURGICAL CLEAR-THERM 3 HEAT MOISTURE EXCHANGER /FILTER, FISHER & PAYKEL - MEDIUM - FULL FACE (REF RTO43M). REMOTE ALARM CABLE IN USE AT THE TIME OF THE EVENT: PRO SIGNAL PSG00089 LEAD, 6.35MM S JACK PLUG-PLUG 2M (FARNELL AV13687). THE DEVICE WAS INSPECTED AND EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER. A PERFORMANCE VERIFICATION TEST WAS CONDUCTED ON THE UNIT WITH NO FAILURE OR MALFUNCTION OF THE DEVICE TO PERFORM TO MANUFACTURER DECLARED SPECIFICATIONS NOTED. FURTHER EVALUATION HAD DETERMINED THE DEVICE ALARM VOLUME ESCALATION FEATURE HAD BEEN TOGGLED ¿OFF.¿ A DIAGNOSTIC REPORT (DRPT) WAS EXTRACTED AND ANALYZED BY PHILIPS PERSONNEL REVEALING A LOW RESPIRATORY RATE ALARM SETTING OF 4 BREATHES PER MINUTE DURING THE TIME OF THE EVENT IN QUESTION. BASED UPON THE FINDINGS DURING DEVICE AND DRPT EVALUATION, THE DEVICE FUNCTIONED AS DESIGNED AND INTENDED WITH NO FAILURE OR MALFUNCTION NOTED. THE DEVICE HAS SUBSEQUENTLY BEEN RELEASED FOR CLINICAL USE. BASED UPON THE INFORMATION PROVIDED AND THE INVESTIGATION FINDINGS, NO FAILURE OR MALFUNCTION OF THE DEVICE TO PERFORM TO MANUFACTURER DECLARED SPECIFICATIONS IS NOTED. DURING AN UNANTICIPATED DISCONNECTION OF THE PATIENT FROM THE DEVICE DURING THERAPY, PATIENT THERAPY DRIVEN ALARMS SUCH AS THE LOW RESPIRATORY RATE ALARM IS EXPECTED TO TRIGGER IF SET APPROPRIATELY. DUE TO THE CLINICAL END USER SETTING THE LOW RESPIRATORY RATE ALARM THRESHOLD AT THE SAME FREQUENCY OF THE DELIVERED BACKUP RESPIRATORY RATE, THE DEVICE LOW RESPIRATORY RATE ALARM HAD UNINTENTIONALLY BEEN DEFEATED. IN THE EVENT THIS OCCURS, THE V60 VENTILATOR WILL NOT PROVIDE AN AUDIBLE OR VISUAL ALARM RELATED TO THE PATIENT RESPIRATORY RATE AND/OR LACK THEREOF. WHEN SETTING THE LOW RESPIRATORY RATE ALARM, THE V60 USER INTERFACE PROVIDES A VISUAL NOTIFICATION WARNING THE CLINICAL END USER THAT THE ALARM HAS BEEN NULLIFIED. FURTHERMORE, THE V60 USER GUIDE STATES IN TABLE 6-4: ALARM SETTINGS: NOTE: IN NON-CPAP MODES, THE LOW RATE ALARM IS ESSENTIALLY OF IF SET BELOW THE RESPIRATORY RATE SETTING. ADDITIONALLY, DURING AN UNANTICIPATED DISCONNECTION OF THE PATIENT FROM THE DEVICE DURING THERAPY, THE DEVICE WILL PROVIDE A PATIENT DISCONNECTION AND/OR PROXIMAL PRESSURE LINE DISCONNECTION ALARM. DURING REVIEW OF THE DRPT, NEITHER ALARM WAS PRESENT DURING THE EVENT IN QUESTION. THE ABSENCE OF THESE ALARMS HAS BEEN ATTRIBUTED TO THE PARTIAL DISLODGEMENT OF THE NIV INTERFACE. AS PER THE V60 USER GUIDE TABLE 11-12: ALARM-RELATED SPECIFICATIONS, THE PATIENT DISCONNECT ALARM REQUIRES 11 SECONDS OF DISCONNECTION IN ORDER TO TRIGGER AND THE PROXIMAL PRESSURE LINE DISCONNECT ALARM REQUIRES 15 SECONDS. IN THE EVENT THAT THE TIME DURATION FOR THESE ALARMS IS NOT MET, THE ALARM WILL NOT TRIGGER. DURING THE EVENT IN QUESTION, IT WAS BELIEVED THAT THE PATIENT NIV INTERFACE BECAME PARTIALLY DISLODGED, THEREBY NOT DISCONNECTED FROM THE PATIENT, HOWEVER NOT IN A POSITION TO PROVIDE ADEQUATE THERAPY. DUE TO A COMBINATION OF INAPPROPRIATE DEVICE ALARM THRESHOLD SETTINGS AND THE ABSENCE OF A PATIENT DISCONNECTION, THE DEVICE WAS NOT EXPECTED TO PROVIDE AN AUDIBLE OR VISUAL REMOTE ALARM NOTIFICATION DURING THE EVENT IN QUESTION. AS THE DEVICE PERFORMED AND FUNCTIONED AS DESIGNED, NO CAUSAL RELATIONSHIP OF THE DEVICE PERFORMANCE TO THE PATIENT OUTCOME HAS BEEN NOTED. HOWEVER, DUE TO THE UNINTENTIONAL USE ERROR OF INAPPROPRIATELY SETTING THE DEVICE ALARM THRESHOLDS, CONTRIBUTION TO THE PATIENT OUTCOME HAS BEEN CONFIRMED.
A 75-YEAR-OLD MALE WITH CO-MORBID CONDITIONS OF ISCHEMIC HEART DISEASE, HYPERTENSION, ATRIAL FIBRILLATION (AF), DYSLIPIDEMIA, ASTHMA, ASBESTOS EXPOSURE, AND AN EX-SMOKER WAS ADMITTED TO THE HOSPITAL FOR AN UNSPECIFIED MEDICAL CONDITION. IN THE LATE EVENING OF (B)(6)2022, HE WAS PLACED ON THE V60 VENTILATOR, CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP MODE). THE PATIENT WENT INTO TYPE 2 RESPIRATORY FAILURE (T2 RF), AND ON (B)(6) 2022 VENTILATOR MODE WAS CHANGED TO BIPAP. CIRCUIT CONFIGURATIONS INCLUDED: BREATHING CIRCUIT - RESPIRONICS BIPAP VISION DISPOSABLE CIRCUIT (REF 582072), WITH NO HUMIDIFIER, AND HAD A FILTER- CLEAR-THERM3 FILTER/HME INTERSURGICAL; INTERFACE FISHER & PAYKEL - MEDIUM - FULL FACE (REF RTO43M). ON THE SAME DATE, WHILE THE DEVICE WAS IN CLINICAL USE WITH BIPAP SETTINGS OF 24:6, THE PATIENT REPORTEDLY REMOVED THE INTERFACE, AND THE END USER STATED THAT THE REMOTE ALARM FAILED TO TRIGGER. A CALL WAS PLACED TO THE MEDICAL ENGINEERING TECHNOLOGIES (MET); HOWEVER, DETAILS OF THE DEVICE EVALUATION WERE NOT REPORTED. THE PATIENT DIED ON (B)(6) 2022. THE EXACT CAUSE OF DEATH WAS NOT REPORTED. MEDICATIONS ON THE DATE OF DEATH INCLUDED FONDAPARINUX 2.5MG SC OD, AUGMENTIN 1.2G IV TDS. ALL OTHER MEDS WERE ON HOLD. THE VENTILATOR VERSION NUMBER WAS 2.30. THE ALARM VOLUME ESCALATION FEATURE WAS DISABLED WHEN THE REPORTED EVENT OCCURRED. THE TYPE OF ALARM CABLE USED WAS PRO SIGNAL PSG00089 LEAD, 6.35MM S JACK PLUG-PLUG 2M (FARNELL AV13687), AND THE ALARM CABLE KITS WERE USED ON NORMALLY OPENED (NO) AND NORMALLY CLOSED (NC) NURSE CALL SYSTEMS PROTOCOLS. THE DEVICE GENERATED 120 D (LOW RATE) WHICH NECESSITATED THE ALARM TRIGGER. FURTHER CLARIFICATION HAS BEEN REQUESTED IF THE REMOTE ALARM SYSTEM WAS CONNECTED TO AN EXTERNAL PHILIPS REMOTE ALARM OR A CENTRAL INSTITUTIONAL ALARM SYSTEM. A PHOTO OF THE CURRENT CONFIGURATION FOR THE REMOTE ALARM WAS REQUESTED BUT WAS NOT AVAILABLE. THE SIGNIFICANT EVENT LOG (DRPT) SHOWED NO DEVICE MALFUNCTION ALARMS OR ANOMALIES NOTED WITHIN THE APPROXIMATE DATE AND TIME OF THE EVENT. ON (B)(6) 2022, WHEN THE PATIENT WAS TRANSITIONED FROM CPAP TO BIPAP MODE, THE FOLLOWING SETTINGS WERE RECORDED AS FOLLOWS: 11: 17:09AM BIPAP, PCRR 4,18, 11:17.28AM BIPAP, PCRR 18,4, 02:35.19PM PCTO2 90, 80, 08:02.25PM, 100% O2 ACTIVATION, 08:03.08PM, PCTO2 80, 100. NO PARTS HAVE BEEN REPLACED AND THE UNIT HAS NOT BEEN REPAIRED BY THE INSTITUTIONAL BIOMEDICAL DEPARTMENT. ON (B)(6) 2022, A PHILIPS AUTHORIZED SERVICE REPRESENTATIVE CONDUCTED A TEST AND VERIFICATION PERFORMANCE, SERVICING AND SAFETY TESTING. THE SYSTEM MET THE SPECIFICATION FOR THE PERFORMED SERVICE AND IS RETURNED TO USE. BASED UPON THE INFORMATION PROVIDED THE DEVICE WAS IN CLINICAL AND THERAPEUTIC USE AT THE TIME OF THE EVENT. THE PATIENT HAD MULTIPLE CO-MORBID CONDITIONS WHICH INCLUDED ISCHEMIC HEART DISEASE, HYPERTENSION, ASTHMA, ATRIAL FIBRILLATION, ASBESTOS EXPOSURE AND WAS AN EX-SMOKER. DURING THERAPEUTIC DELIVERY OF POSITIVE PRESSURE VENTILATION FOR TYPE 2 RESPIRATORY FAILURE, THE PATIENT REPORTEDLY REMOVED THE INTERFACE, AND THE END USER STATED THAT THE REMOTE ALARM FAILED TO TRIGGER. THE PATIENT DIED, WITH EXACT CAUSE OF DEATH NOT REPORTED. BASED UPON THE INFORMATION PROVIDED AND INVESTIGATION CONDUCTED, THE DEVICE DID NOT FAIL TO PERFORM TO MANUFACTURER DECLARED SPECIFICATIONS. THE SIGNIFICANT EVENT LOG SHOWED NO DEVICE MALFUNCTION ALARMS NOTED WITHIN THE DATE OF THE EVENT. NO CAUSAL RELATIONSHIP HAS BEEN DEFINED WITHIN THIS COMPLAINT RECORD OF THE ALLEGED DEVICE MALFUNCTION AND THE PATIENT EXPIRATION. CONTRIBUTION OF THE DEVICE TO THE PATIENT OUTCOME CANNOT BE RULED OUT BASED UPON THE UNINTENTIONAL USER ERROR NOTED OF IMPROPERLY CONFIGURING THE VENTILATOR SETTINGS IN WHICH THE DEVICE DID NOT RECOGNIZE THE LOW-RATE ALARM WHEN THE PATIENT¿S RESPIRATORY RATE DROPPED BELOW PRESET LEVEL. THE USE OF UNAPPROVED CIRCUITS WERE USED, AND AN EXTRA FILTER-IN LINE (BIPAP VISION, HME), ALONG WITH UNAPPROVED CABLE ALARMS COULD HAVE RESULTED IN A DEFEAT OF THE DISCONNECTION ALARM OR EFFICACY OF OTHER ALARMS. AS PER THE V60 VENTILATOR USER GUIDE (¿PARTS AND ACCESSORIES', SECTION C-3, IT IS RECOMMENDED TO USE ONLY RESPIRONICS-APPROVED ACCESSORIES WITH THE VENTILATOR TO ENSURE THE CORRECT PERFORMANCE OF THE VENTILATOR. RESISTIVE COMPONENTS CAN INCLUDE BUT ARE NOT LIMITED TO HMES, PROXIMAL FLOW SENSORS, A FILTER AT THE PATIENT CONNECTION, OR A NARROW DIAMETER CIRCUIT ATTACHED TO A MASK.
IT WAS REPORTED TO PHILIPS THAT A V60 DEVICE HAD A REMOTE ALARM FAILURE THAT LED TO A PATIENT¿S DEATH. A PATIENT OF UNKNOWN AGE, GENDER, AND MEDICAL HISTORY WAS PRESCRIBED A V60 DEVICE WITH UNKNOWN MODE, SETTINGS, CONFIGURATIONS, AND ALARM SETTINGS. ALLEGEDLY, THE DEVICE FAILED TO TRIGGER THE REMOTE ALARM WHICH LED TO PATIENT DEATH. THE FIELD SERVICE ENGINEER DOWNLOADED DIAGNOSTIC REPORT AND CONFIRMED ALARMS ARE FUNCTIONING PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2333318 | RESPIRONICS | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE | MNT | RESPIRONICS CALIFORNIA, LLC | V60 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male | Death |