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

Model Number V60

Device Problem Medical Gas Supply Problem (2985)

Patient Problem Respiratory Distress (2045)

Event Date 08/28/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report:(b)(6) 2020.

Event Description

A customer reported to philips that the respironics v60 ventilator generated an alarm while in use on a patient during transport, when the oxygen tanks became depleted, and that the patient was intubated a day later.The customer reported that the unit was in use on patient during the reported device symptom, and that the patient incurred the adverse event as a result of the reported hazardous situation.

Manufacturer Narrative

G4: 04nov2020 b4: (b)(6)2020 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 ventilation therapy via the respironics v60 ventilator; prescription, device settings, configuration, patient circuit, and patient interface not reported.While admitted on (b)(6) 2020, the patient was being transported and receiving ¿high volume oxygen¿ therapy via the v60 device, when the oxygen tanks emptied, the device generated an alarm, and the patient was intubated a day later.The alarms generated by the device were not reported.No relevant laboratory data was reported.No diagnostic report was provided for review.The patient was not receiving high flow therapy, but was receiving a high amount of fio2; values not reported, and was breathing at a high respiratory rate; values not reported, which caused the oxygen tanks to become depleted.A philips field service engineer (fse) evaluated the device and was unable to duplicate the symptom.No parts were replaced.The device passed all performance verification testing and was placed back into use with the customer.There was no malfunction of the device.The device was working as intended when the ventilator generated an alarm, alerting the hospital staff to a low oxygen supply condition.Users must always check the status of the oxygen cylinders before using the ventilator during transport, make sure all cylinders are full (13,790 kpa/2000 psig or more), make sure the cylinder regulators are turned off while the ventilator is connected to wall oxygen, and never turn the cylinder regulator on until you are ready to begin transport (respironics v60/v60 plus ventilator, user manual, publication number 1047358, revision u, (b)(6), page 5-10).The root cause is due to user error.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
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 10555642
• MDR Text Key: 207608363
• Report Number: 2031642-2020-03331
• 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,Followup
• Report Date: 09/02/2020

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: 09/02/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER; UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Outcome(s): Required Intervention