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

Model Number V60

Device Problem Defective Alarm (1014)

Patient Problem Respiratory Insufficiency (4462)

Event Date 06/17/2022

Event Type  Death  

Event Description

The customer reported that the patient went into distress after removing his mask; the nurses did not hear an alarm from the system.A male patient of unknown age and medical history was on a v60 ventilator for ventilatory support.On (b)(6) 2022 at approximately 7:15pm, while the device was in clinical and therapeutic use, the nurses responded to a patient distress and discovered that the patient had removed his mask, and the device did not annunciate an alarm.The customer stated the alarms were not heard by the nurses due to low pressure/low volume alarm, with the following parameters provided: alarms setting - low rate at 10 - low title volume 100 cc - low pressure 5cm of water - low minute ventilation set up at 4 liters.On (b)(6) 2022, the respiratory therapist tested the system a total of 12 times, and all tests resulted in the alarm functioning correctly.The system was removed from service.

Manufacturer Narrative

(b)(6).Further information has been requested.If additional information becomes available at a later date, a supplemental report will be submitted.

Manufacturer Narrative

The following is a revised investigation summary incorporating information received by a philips field service engineer (fse) from the charge nurse of the respiratory department: the fse indicated that all information provided was given through a second-hand account by the charge nurse of the respiratory department and direct contact was not made with the individual who witnessed the event.A 72-year-old male who was severely ill and an inpatient in a stepdown unit was placed on a v60 ventilator (version 3.0) for ventilatory support.System settings and prescriptions were set as 12/8, rate 10, 30%, it=1.0., rise 4 and ramp was off; alarm settings included high rate 50, low rate: 10, hi vt 2500, low vt 100, hip 40, lip 5, low ve 5, lipt 20.There was no water trap in line in the circuit.On (b)(6) 2022 the staff were notified of patient distress through a monitoring equipment at the nursing station.Upon arrival in the patient¿s room, they discovered that the patient had removed his mask and did not hear any audible alarm.It was unknown what position the mask was in when found by the staff.The mask was immediately reattached by staff upon discovery.The patient died on (b)(6) 2022 at approximately 7:15 pm.The cause of death was cardiac congestive heart failure.The charge nurse indicated that the patient was severely ill, and his passing was not unexpected.The device did not have alarm volume escalation enabled at the time of the incident.The hospital commented that the device did not cause or contribute to the patient's death.The hospital reduced the incident from a level 5 (being the highest alert) to a level 1 (being the lowest alert) before contacting philips.The device alarmed during simulation testing conducted by the institutional staff.On 17-jun-2022, the event log revealed isolated episodes of diagnostic code 1200 (patient disconnect) and 1211 (high rate), and multiple episodes of 120e (low minute ventilation).After the incident, the device was not tested by the institutional biomedical department and alarm testing after the incident was not formally documented.No parts were replaced.The system is currently not in use by the hospital as it was pulled from service following this incident.A philips field service engineer (fse) is scheduled to conduct an onsite visit on (b)(6) 2022.The device is pending on site device evaluation by a philips fse.

Manufacturer Narrative

The indication for v60 ventilator therapy is congestive heart failure.The customer indicated that the are 100% confident it was not a product failure but a clinical use and patient issue.On 17-jun-2022 at 7:15 pm, the event log confirmed the presence of diagnostic code1200 (patient disconnect).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 clinical staff was notified of patient distress via monitoring equipment at the nursing station.The patient was found to have removed his mask.The alarm volume escalation was not enabled at the time of the incident.The mask was immediately attached to the patient upon discovery.The patient died on the same day of the incident with cause of death reported as cardiac congestive failure.Other relevant clinical details and intervention rendered preceding the fatal outcome were not reported.The nurse in charge indicated that the patient was severely ill, and his death was not unexpected.The institution commented that the device did not cause or contribute to the patient¿s death.Further investigation yielded that the device alarmed during simulation testing conducted by the institutional staff.However, the device was not tested by the institutional biomedical department and alarm testing after the incident was not formally documented.The device was removed from service, and an onsite site visit from a philips¿ field service engineer (fse) has been scheduled.Based upon the information provided and pending further device evaluation, philips is unable to establish a causal relationship between the allegation of no audible alarm and patient outcome.At the time of reporting, the device has been removed from service.However, contribution of the device to the patient outcome can be confirmed based upon the unintentional use error noted of patient mask disconnection and subsequent unanticipated disruption to the therapeutic delivery.The event log revealed the presence of diagnostic code 1200 (patient disconnect) on the date and time of patient¿s death.

Manufacturer Narrative

Clinical risk review.The alleged malfunction described in the complaint has been reviewed by philip¿s clinical risk manager.As per the v60 user guide general warnings: an alternative means of ventilation shall be available whenever the ventilator is in use.If a fault is detected in the ventilator, disconnect the patient from it and immediately start ventilation with such a device.Use the respironics v60/v60 plus ventilator on spontaneously breathing patients only.It is an assist ventilator and is intended to augment the ventilation of a spontaneously breathing patient.It is not intended to provide the total ventilatory requirements of the patient.To ensure the ventilator¿s safe operation, always verify ventilator operation as described in ¿verify ventilator operation¿ on page 5-7 before using the ventilator on a patient.If the ventilator fails any tests, remove it from clinical use immediately.Do not use the ventilator until necessary repairs are completed and all tests have passed.The device has been inspected by an authorized philips service technician and no fault or malfunction was found with the device in relation to the reported problem.Alarm audible and visual functionality were confirmed to be within declared specifications with no evidence of fault or malfunction.Device diagnostic report logs have been collected and reviewed with no anomaly found.Device diagnostic report logs have been collected and reviewed by philip¿s clinical risk manager with no anomaly found.Based upon the information provided and evidence recorded, no fault or malfunction has been determined and therefore clinical review of reasonable worst-case for potential severity is not applicable.Clinical review of overall contextual severity for this complaint has been designated as level 4, catastrophic - directly results in death or catastrophic property or environmental damage.During the event in question, it was alleged that during an unintentional disconnection of the patient interface from the v60 breathing circuit, the patient was subsequently reattached to the device, however the patient expired status-post event (unspecified timeframe).Provision of medical intervention was not divulged to philips respironics.Investigation findings determined the device was performing to manufacturer declared specifications with no failure or malfunction noted.Device inherently safe design risk control measures permit patients within labelled indications for use to continue spontaneous breathing while connected to the ventilator in the event of a complete cessation of flow/therapy.Further investigation determined the device appropriately alarmed with several patient therapy alarms (1200 patient disconnect, 1211 high rate) triggering audibly and visually at the time of the event.Further risk review and assessment has been completed as far as possible.Philips risk analysis for use of this device remains acceptable with no further action required.

• 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: 14878879
• MDR Text Key: 295105342
• Report Number: 2031642-2022-01756
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• 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?: No
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 07/06/2022; 08/05/2022; 01/25/2023
• Supplement Dates FDA Received: 07/28/2022; 08/22/2022; 01/27/2023
• Date Device Manufactured: 12/12/2013
• 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: 72 YR
• Patient Sex: Male