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

Model Number V60

Device Problem Disconnection (1171)

Patient Problem Death (1802)

Event Date 06/10/2020

Event Type  Death  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 29jun2020.

Event Description

A customer reported to philips that the v60 ventilator disconnected from a patient and the patient experienced an outcome of death.The device was in use on a patient at the time the outcome occurred.

Manufacturer Narrative

G4: 02nov2020.B4: 04nov2020.H11: h1: correction from serious injury to death.H10: review of the provided diagnostic report from on (b)(6) 2020, showed that the device was running on a/c power, and the device generated three ¿patient disconnect¿ alarms between the time of 01:54.23 pm and 03:09.30 pm.The field service engineer replaced the gas delivery system.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 ventilation therapy via the respironics v60 ventilator; device configuration, settings, patient circuit, and patient interface not reported.While admitted on (b)(6) 2020, the patient was receiving bipap therapy s/t mode from the v60 device, the device generated a patient disconnect alarm, and the patient experienced an outcome of death.No relevant laboratory data was reported.One gas delivery subsystem (gds) was returned to the failure investigation laboratory for analysis.Visual inspection revealed no anomalies.The returned gds failed airflow testing.The test system performed normally with the returned gds installed when the output restrictor was removed.The returned gds passed pressure and leak testing.Returned gds failed airflow testing.Root cause was failure of airflow sensor, caused by u1 drifting out of calibration.The test system performed normally with the returned gds installed when the output restrictor was removed.The returned gds passed pressure and leak testing.The root cause was failure of airflow sensor, caused by u1 drifting out of calibration.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: 10209887
• MDR Text Key: 196922953
• Report Number: 2031642-2020-02228
• 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: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• 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
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Outcome(s): Death