MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problems Complete Blockage (1094); Device Displays Incorrect Message (2591)

Patient Problems Death (1802); Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 09feb2021.

Event Description

A customer reported to philips that while delivering high flow therapy to a patient, the respironics v60 ventilator generated a cannot reach target flow alarm, and the patient experienced an event of oxygen desaturation.The customer reported that the unit was in use on a patient at the time of the reported device behavior and adverse event.There was no request for a field service engineer (fse) onsite visit and no service order was opened in regards to this allegation.This complaint was received through the customer feedback process.There was no request for technical support regarding this allegation and there is no record of a service order being opened.Philips is unable to confirm the customers allegation since there was no technical support requested.No diagnostic report was provided for review.The cannot reach target flow is a low priority alarm that may occur during high flow therapy.The alarm is generated when the machine pressure reached its maximum and could not achieve the target flow.The recommended repair is to check the patient, check that the nasal cannula size is appropriate for the flow setting, check that an occlusive interface is not in use, and check the patient circuit for occlusions, kinks, or liquid (respironics v60/v60 plus ventilator, service manual, publication number 1049766, revision k, page 103).No parts were replaced.The device passed all performance verification testing and was placed back into use with the customer.This reporter stated that a female patient of unknown age, height, and weight was admitted to a hospital on an unknown date with an admitting diagnosis of coronavirus (covid 19).Relevant medical history included obstructive sleep apnea and obesity.No relevant past drug history or relevant concomitant medical products were reported.While admitted on an unknown date, the patient was prescribed nocturnal bi-level positive airway pressure (bipap) therapy and diurnal high flow therapy via the respironics v60 ventilator.The details of the bipap prescription were not reported.The high flow therapy prescription included a philips ac611 high flow nasal cannula; size not reported, fisher & paykel mr850 respiratory humidifier, fisher & paykel mr290 adult humidifier chamber, a flow rate of 60 liters per minute (l/min), and 100% fraction of inspired oxygen (fio2).The patient circuit model was not reported.While admitted on an unknown date in (b)(6) 2021, the patient was sitting in a chair not in distress, receiving high flow therapy via the v60 device at 50-60 l/min, the device generated cannot reach target flow alarms, the flow stopped for one to two seconds, the patient experienced an event of decreased peripheral capillary oxygen saturation; values not reported, the hospital staff then changed the flow rate to 30-40 l/min, and the cannot reach target flow (122d) alarm resolved.Hospital staff then increased the flow rate to 50-60 l/min and the cannot reach target flow (122d) alarm occurred again.The patient did not prone during high flow therapy and refused to be intubated and placed on mechanical ventilation therapy.No relevant laboratory data was reported.On an unknown date days later, the patient experienced an outcome of death.The cause of death was not reported.The reporter stated that the patient's outcome was not related to the ventilator, but was associated with the patient's admitting diagnosis and co-morbidities.The reporter also stated that the alarm occurred due to a possible occlusion of the high flow nasal cannula.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 11304265
• MDR Text Key: 231115702
• Report Number: 2031642-2021-00478
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 01/24/2021

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2021
• Initial Date FDA Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening