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

Model Number V60

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiopulmonary Arrest (1765); Low Oxygen Saturation (2477)

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 12feb2021.

Event Description

A customer reported to philips that while receiving high flow therapy from the respironics v60 ventilator, a patient experienced an event of oxygen desaturation and cardiopulmonary arrest.The customer reported that the unit was in use on a patient at the time of the reported device behavior and adverse event.

Manufacturer Narrative

G4:(b)(6) 2021.B4:(b)(6)2021.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 customer¿s allegation since there was no technical support requested.No diagnostic report was provided for review.The cannot reach target flow (122d) 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 patient of unknown age, gender, height, and weight was admitted to a hospital on an unknown date with the admitting diagnosis not reported.No relevant medical history, relevant past drug history or relevant concomitant medical products were reported.While admitted on an unknown date, the patient was prescribed high flow therapy via the respironics v60 ventilator with software version 3.0 via a fisher and paykel high flow nasal cannula size not reported; prescription, device settings, configuration, and patient circuit not reported.While admitted on (b)(6) , the patient was receiving high flow therapy in the prone position via the v60 device, there appeared to be pressure building up in the circuit, the device generated cannot reach target flow (122d) alarms, the v60 seemed to respond when the hospital staff decreased the flow rate and pressure while the alarm was active, the patient experienced an event of significant oxygen desaturation; values not reported, and cardiopulmonary arrest.Hospital staff then administered cardiopulmonary resuscitation rescue efforts, the patient was revived, intubated, was prescribed invasive ventilation, and the event of oxygen desaturation improved; values not reported.On an unknown date, the mechanical ventilation prescription was discontinued and the patient was extubated.No relevant laboratory data was reported.There is no information to support that a malfunction occurred.The device was behaving as intended when it alerted the user to an occlusive condition.The cannot reach target flow alarm is an expected device behavior when an occlusion occurs in the patient circuit and the machine pressure is outside the range to delivery therapy.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11322932
• MDR Text Key: 231658324
• Report Number: 2031642-2021-00564
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

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: 02/05/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 03/13/2021
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER; UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Outcome(s): Life Threatening