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

Model Number V60

Device Problem Obstruction of Flow (2423)

Patient Problems Cognitive Changes (2551); Lethargy (2560)

Event Date 04/29/2021

Event Type  Injury  

Event Description

A customer reported to philips that a patient experienced an event of lethargy and altered mental status while receiving ventilation therapy via the respironics v60 ventilator.The customer reported that the unit was in use on a patient at the time of the reported adverse event.A philips field service engineer (fse) evaluated the device and did not duplicate the symptom.Review of the provided diagnostic (drpt) showed the device did not generate any error codes or any low leak carbon dioxide rebreathing risk alarms.However, the drpt did show the device generated several low inspiratory pressure (1207), patient disconnect (1200), proximal pressure line disconnect (1202), low oxygen supply pressure (1209), and oxygen not available (1208) alarms.No parts were replaced and the software version was upgraded to version 3.0.The device passed all performance verification tests and was placed back into use with the customer.This reporter stated that a (b)(6) years old female patient with unknown height, and weight was admitted to a hospital on an unknown date with the admitting diagnosis not reported.Relevant medical history included obstructive sleep apnea; diagnosis date not reported.Relevant concomitant medical products included at home bi-level positive airway pressure (bipap) therapy; device not reported.No relevant past drug history was reported.While admitted on an unknown date, the patient was prescribed nocturnal ventilation therapy via the respironics v60 ventilator in average volume-assured pressure support (avaps) mode, a respironics performax full-face mask; size not reported, and a medline patient circuit; model and lot number not reported.The ventilation prescription, device settings and configuration were not reported.While admitted on an unknown date, the patient was receiving nocturnal therapy via the v60 device for approximately six to seven hours, when the patient experienced an event of lethargy and altered mental status; level of consciousness not reported.The patients medication regimen was then changed; details not reported, the hospital staff noticed that the exhalation port was plugged (capped), and the device did not generate a low leak carbon dioxide rebreathing risk alarm.No relevant laboratory data was reported.The following day, the event of altered mental status resolved.On an unknown date, the patient was discharged from the hospital to an assisted living facility.To prevent possible asphyxia and to reduce the risk of co2 rebreathing, the user should use only an oro-nasal mask with an anti-asphyxia valve or a nasal mask for noninvasive ventilation, the exhalation port should not be occluded, the user should verify that the port is operational before application, and the user should inspect and verify the proper operation of the exhalation port regularly during use (respironics v60/v60 plus ventilator, user manual, publication number 1047358, revision u, september 2019, pages 1-3, 1-4, and 1-7).There was no malfunction of the device.The user did not verify the proper operation of the exhalation port, prior to the initiation of therapy, or throughout the administration of treatment.The patient's adverse event was due to the improper use of the patient circuit.

Manufacturer Narrative

There was no malfunction of the device.The compromised therapeutic response from the v60 ventilator as a result of user error in which the proper operation of the exhalation port was not verified.As per the v60 ventilator user guide, the exhalation port should be checked for occlusions before and during clinical use of the device.

• 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: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 11952782
• MDR Text Key: 254883083
• Report Number: 2031642-2021-03987
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

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
• Distributor Facility Aware Date: 05/10/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 03/09/2022
• Supplement Dates FDA Received: 04/05/2022
• Date Device Manufactured: 09/02/2011
• 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): Required Intervention
• Patient Sex: Female