MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60

Device Problem No Audible Prompt/Feedback (2282)

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461); Insufficient Information (4580)

Event Date 06/01/2022

Event Type  Death  

Event Description

The institutional biomedical engineer (bme) reported that per the end user, the v60 ventilator became disconnected from the patient.The end user stated that the unit had visual alarms, however it did not generate audible alarms.A patient of unknown age and gender was admitted to the hospital for respiratory distress and was placed on a v60 ventilator (unknown settings and configurations).On an unknown date, the patient became disconnected from the v60 device.At the time of the event, there were unspecified visual alarms, however no audible alarms were generated.The patient expired.Clinical details surrounding the disconnection from the device were not reported.The bme stated that he had checked the unit and that unit alarmed both audibly and visually.He noted that the alarm volume was set to 2 and that alarm escalation feature was turned off.The bme has requested for an onsite evaluation and service from philips.The device was evaluated by a philips authorized service representative.The significant event log (drpt) revealed no error related to alarm issues and no failures reported.Initial examination of the device showed fully functioning alarm.The onsite service engineer recommended further follow-up work on the system which includes replacing the speakers, power management board and motor controller board.

Manufacturer Narrative

The following is a revised investigation summary incorporating information received from the risk manager via responses to good faith efforts, with supplemental information received from a voluntary report from the fda on behalf of the risk manager via the fda's medwatch program (mdr report no: mw5110089).The patient was a 65-year-old male (height: not reported; weight: 158.8, with unit of measurement [kg vs.Lb.] not reported) with relevant medical history which included pulmonary diagnoses of acute respiratory failure with hypoxia, with concurrent diagnoses of type 2 diabetes, hypertension, obstructive sleep apnea on cpap, and paraplegia.On (b)(6) 2022, he presented to the emergency department (ed) for respiratory distress with sudden onset of shortness of breath.The patient had chest tightness earlier in the day.During the ed visit, the patient was started on the v60 ventilator (version 3.0), bipap mode.Device accessories included a heated humidifier- teleflex- neptune model 425-00.For the ventilator settings, the risk manager stated that per their institutional policy, the v60 alarm settings are patient specific based on height and weight.There is no standard of care, and each alarm is tailored to prevent nuisance alarms as well as to give appropriately safe coverage of the patient.On (b)(6) 2022, while the device was in clinical use, the patient died.The clinical details leading to the time of death were reported by the risk manager as follows: the v60 was working properly.It alarmed appropriately and showed volumes received and delivered until the disconnect alarm sounded.Due to the decreasing vitals that were charted by the registered nurses (rns) and at the time of disconnect, the fact that there was no spontaneous breathing noted by the v60, it was hypothesized that the patient had a medical event and slumped over, and the tubing was disconnected from the patient's bipap mask.After the tubing disconnection, the bipap alarm went off for 6 minutes.The alarm was set on 2 of 10 and was not heard by the staff.At the time of the event, the auto-trak+ option was not installed, and the alarm volume escalation feature was not enabled.The patient's heart rate dropped, and the physician was alerted.The patient was found unresponsive, pulseless, and apneic.A code blue was called.It was unclear if the bipap disconnection led to the patient's respiratory/cardiac arrest or if the patient had a medical event prior to the mask disconnection.The risk manager stated that at this point, they believed that the patient had a medical event prior to the alarm issue.There was a 5-to-6-minute delay in care related to staff not being able to hear the disconnect alarm.She commented that they found out that even when the alarm setting was turned up to 10, the alarm could not be heard at the nurse¿s station with the door of the patient¿s room closed.The device was evaluated by the hospital biomedical department which included the following findings: v60 service logs record date and time associated settings and alarms.-device was turned on at 13:11 on 5/20- speaker self-test passed- at 13:13 bipap sti 15, bipap ste 5, strr -26, rise time of 2, stinh time.8,ramp time 5, pct o2 40, at 13:17 mode cpap st, bipap strr26,22, bipap strr 22,20.At 13:21 low priority alarm high tidal volume x2 at 13:41 high priority alarm, low inhalation pressure, low priority alarm high tidal volume (changes to high priority after sixty seconds) high tidal volume continued to alarm until 13:46.High priority proximal line disconnect alarm sounded at 13:43 all indicators point to the alarms sounding for 6 minutes from the first alarm to the last with full disconnect being noted after 2 minutes.The engineer ascertained that the alarm volume was set at 2, which was confirmed by a co-worker who stated that the alarm volume was set at 2 when the device was turned on.(scale 1-10) alarm function was tested.It passed.It was noted that in the setting for the device the alarm volume escalation is turned off- when on, this escalates the set volume to maximum volume if operator input is not detected within 40 seconds.A philips fields service engineer (fse) evaluated the device and found no associated errors, with device operating as designed.At the time of reporting, no parts had been replaced.The device remained sequestered in the facility's clinical engineering department.The risk manager indicated that the v60 was working properly.It alarmed appropriately and showed volumes received and delivered until the disconnect alarm annunciated.There were no associated errors found during device evaluation conducted by a philips fse.

Manufacturer Narrative

The risk manager indicated that the patient monitoring alarm was via telemetry.Based upon the information provided the device was in clinical and therapeutic use at the time of the event.During therapeutic delivery of positive pressure ventilation, the patient had mask had become disconnected from the breathing circuit.During the disconnection state, an absence of the v60 ventilator disconnection alarm was noted.During the event, the patient experienced a significant change in condition, ultimately resulting in advanced life saving cardiovascular interventions.The result of the administered care was unsuccessful and the patient subsequently expired.Further investigation yielded information from the institutional risk manager that the patient may have suffered a catastrophic medical event prior to the unintended disconnection from the therapy, however, certainty could not be determined.The further device investigation conducted by a philips field service engineer yielded no anomalies or failure of the device performance to manufacturer declared specifications.It was discovered that during therapeutic use, the patient breathing circuit configuration did include use of a teleflex- neptune model 425-00 humidifier.As per the v60 ventilator user guide ( 'parts and accessories', section c-3).Based upon the information provided and investigation conducted, the device did not fail to perform to manufacturer declared specifications.The absence of the patient disconnection alarm during a noted patient disconnection from the device can be attributed to the use of unapproved accessories (teleflex humidifier) which as previously stated, may affect device performance and efficacy of alarm detection and patient disconnection thresholds.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 definitively ruled out based upon the unintentional use error noted of patient disconnection and subsequent unanticipated disruption to the therapeutic delivery.

Manufacturer Narrative

H10: a3 and b7 were updated based on previous information submitted.H10: although no errors were identified with the device, due to the customer's concern on age of the speakers, power management board and motor controller board, the fse recommended replacing the boards as a preventative measure to secure the boards for blue-room analysis.The fse indicated that he has not been unable to procure the boards as they are on backorder.H11: on (b)(6) 2022, he presented to the emergency department (ed) for respiratory distress with sudden onset of shortness of breath.The patient had chest tightness earlier in the day.During the ed visit, the patient was started on the v60 ventilator (version 3.0), bipap mode.Device accessories included a heated humidifier- teleflex- neptune model 425-00.For the ventilator settings, the risk manager stated that per their institutional policy, the v60 alarm settings are patient specific based on height and weight, and each alarm is tailored to prevent nuisance alarms as well as to give appropriately safe coverage for the patient.On (b)(6) 2022, while the device was in clinical use, the patient died.The clinical details leading to the time of death were reported by the risk manager as follows: the v60 was working properly.It alarmed appropriately until the disconnect alarm annunciated.Due to the decreasing vitals that were charted by the registered nurses (rns) and at the time of disconnect, the fact that there was no spontaneous breathing noted by the v60, it was hypothesized that the patient had a medical event and slumped over, and the tubing was disconnected from the patient's bipap mask.The alarm was set on 2 of 10 and was not heard by the staff.At the time of the event, the alarm volume escalation feature was not enabled.The patient's heart rate dropped, and the physician was alerted.The patient was found unresponsive, pulseless, and apneic.A code blue was called.It was unclear if the bipap disconnection led to the patient's respiratory/cardiac arrest or if the patient had a medical event prior to the mask disconnection.The device was evaluated by an institutional biomedical engineer who ascertained that the alarm volume was set at 2, which was confirmed by a co-worker who stated that the alarm volume was set at 2 when the device was turned on.The device passed the alarm functionality test.A philips fields service engineer (fse) conducted an on-site device evaluation and found no associated errors, with fully functioning alarm.The significant event log (drpt) revealed no error related to alarm issues and no failures.Further philips' internal review of drpt identified the following settings and alarms; on 20-may-2022; the device was turned on at 11:21am.The device speakers passed post testing.Ventilator settings were at bipap ipap 15, epap 5, rr-26, rise time 2, i-time.8, fio2 40%.Repeated high vt alarms were observed throughout 20-may-2022 however, no patient disconnect alarms were noted.The use of an unapproved humidifier (v60 ventilator service manual, 'parts and accessories', section c-3) can contribute to the device not detecting patient disconnect ('warnings, cautions, and notes', section 1-3).Although no errors were identified with the device, due to the customer's concern on age of the speakers, power management board and motor controller board, the fse recommended replacing the boards as a preventative measure to secure the boards for blue-room analysis.The fse indicated that he has not been unable to procure the boards as they are on backorder.Based on the information provided, philips is unable to establish a direct causal relationship between the fatal event and device issue.Device functionality was confirmed as there were no associated errors found during device evaluation conducted by a philips fse.Additionally, the institution utilized teleflex- neptune model 425-00 humidifier (not an approved accessory) on the v60 device which can lead to the device not functioning properly ultimately not detecting patient disconnect.As a result, patient's admitting diagnosis of acute respiratory failure with hypoxia and cease of therapy contributed to the patient's death.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: kimberly shelly ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 14787669
• MDR Text Key: 294585629
• Report Number: 2031642-2022-01670
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/23/2022
• Supplement Dates Manufacturer Received: 06/01/2022; 07/15/2022; 08/03/2022
• Supplement Dates FDA Received: 06/29/2022; 08/01/2022; 08/22/2022
• Date Device Manufactured: 08/26/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Sex: Male