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 Problem Death (1802)

Event Date 11/19/2020

Event Type  Death  

Manufacturer Narrative

Date of event: (b)(6) 2020, date of report: 10dec2020.

Event Description

A customer reported to philips that a patient removed themselves from the respironics v60 ventilator, the device did not alarm, and the patient experienced an outcome of death.A philips field service engineer (fse) evaluated the device and was unable to duplicate the symptom.During the evaluation, the fse noted that the device was set audio alarm loudness 10.No error codes were reported, and no diagnostic report (drpt) was provided for review.The customer reported that the unit was not in use on a patient at the time of the reported device symptom and patient outcome.At the time of death, the patient was not receiving therapy and was not on the unit.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 ventilation therapy via the respironics v60 ventilator with software version 2.3; prescription, device settings, configuration, patient circuit, and patient interface not reported.While admitted on an unknown date, the patient was receiving therapy via the v60 device, when the patient removed themselves from the device and stopped receiving therapy.Then at a time and date not reported and while not receiving therapy, the patient experienced an outcome of death.Neither the primary nor secondary cause of death was reported.No relevant laboratory data was reported.The reporter stated that there was no malfunction of the device, and that there was no temporal association between the v60 ventilator and the patient's outcome.Audio alarm loudness 10, is the highest volume setting, where the average sound pressure level is approximately 76 decibels.There was no malfunction of the device.The patient removed themselves from the ventilator, thereby discontinuing their therapy.

Manufacturer Narrative

Date rec'd by mfr: 11dec2020.Date of report: 14dec2020.The trending analysis indicates that there is no systemic issue, therefore no further investigation or action is warranted at this time.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

The occurrence date of the patient removing themselves from the ventilator was on (b)(6) 2020.Review of the received diagnostic report (drpt) showed that the device was in use on (b)(6) 2020, no error codes were generated, and multiple low minute ventilation (120e), low tidal volume (120f), and high tidal volume (1210) alarms were produced.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: 10987644
• MDR Text Key: 220889815
• Report Number: 2031642-2020-04469
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• 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,Followup
• Report Date: 11/23/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 11/23/2020; 11/23/2020
• Supplement Dates FDA Received: 12/15/2020; 01/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2020
• 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