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 Asystole (4442)

Event Date 01/06/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2021.(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 therapy from the respironics v60 ventilator, the patient experienced a flat line.The customer reported that the unit was in use on a patient at the time of the reported adverse event.

Manufacturer Narrative

G4: 24feb2021.B4: 24feb2021.H11: g5:k102985.H10: philips field service engineer (fse) evaluated the device and was unable to duplicate the symptom.Review of the provided diagnostic report (drpt) showed no error codes were generated.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; software version 2.30, prescription, device settings, configuration, patient circuit, and patient interface not reported.While admitted on (b)(6) 2021, the patient was receiving therapy via the v60 device and the patient ¿flat lined¿.No relevant laboratory data was reported.No medical intervention was reported and the outcome of the patient experiencing a flat line is unknown.Philips was not able to confirm the reported malfunction.Philips contacted with the hospital many times, but the hospital did not provide any details about the injury event.No conclusion can be drawn as the customer declined to provide additional information.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

G4: (b)(6) 2021.B4: (b)(6) 2021.A philips field service engineer (fse) evaluated the device.No device symptom was reported during the adverse event, and no device symptom was reported during the device evaluation.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: 11276702
• MDR Text Key: 230213807
• Report Number: 2031642-2021-00426
• 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,Followup
• Report Date: 01/21/2021

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 01/21/2021; 01/21/2021
• Supplement Dates FDA Received: 02/24/2021; 04/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2012
• 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): Life Threatening