MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC 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 Pulmonary Emphysema (1832); Infiltration into Tissue (1931)

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6) 2021.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.

Event Description

A customer reported to philips that while receiving high flow therapy from the respironics v60 ventilator, a patient experienced an event of subcutaneous emphysema.The customer reported that the unit was in use on a patient at the time of the reported adverse event.

Manufacturer Narrative

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 device alarms or error codes were reported.No diagnostic report was provided for review.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 an admitting diagnosis of coronavirus (covid 19).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 a philips ac611 high flow nasal cannula; prescription, device settings, configuration, patient circuit, and patient interface size not reported.While admitted on (b)(6) 2021, the patient was receiving high flow therapy via the v60 device at a flow rate of 80 liters per minute when the patient experienced an event of subcutaneous emphysema.Relevant laboratory data included a chest x-ray that identified the pneumothorax.The patient underwent placement of a chest tube on an unknown date; details were not provided.As of (b)(6) 2021, the chest tube has been removed, and the event of subcutaneous emphysema has resolved.The reporter stated that the adverse event was not related to the device or the high-flow therapy.There is no information to support that a malfunction occurred.Philips was unable to determine the cause of the reported event.No conclusion can be drawn as the customer declined to have the equipment evaluated.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.

Manufacturer Narrative

No parts were replaced.Based upon the information provided, no further investigation, testing, or evaluation was conducted on the v60 ventilator in question.

• 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
• Manufacturer (Section G): RICA; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: yobana sanchez ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 11322815
• MDR Text Key: 238728985
• Report Number: 2031642-2021-00563
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2022

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?: No
• 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
• 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; 03/10/2022
• Supplement Dates FDA Received: 04/15/2021; 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2018
• 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
• Patient Outcome(s): Required Intervention