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

Model Number V60

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 12/09/2020

Event Type  Death  

Manufacturer Narrative

Event date: (b)(6) 2020.Report date: 16dec2020.

Event Description

A customer reported to philips that while delivering therapy to a patient, the respironics v60 ventilator generated an alarm with details not reported, the patient circuit might have become disconnected from the patient, and the patient experienced an outcome of death.The customer reported that the unit was in use on a patient during the time of the reported device symptom and patient outcome.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 receiving therapy via the v60 device, the device generated alarms, the patient circuit might have become disconnected from the patient, and the patient experienced an outcome of death.The alarms generated by the device were not reported.No medical intervention was reported.No relevant laboratory data was reported.Neither the primary nor secondary cause of death were reported.

Manufacturer Narrative

G3: (b)(6) 2021.There was no request for a field service engineer (fse) onsite visit and no service order was opened in regards to this allegation.This complaint was received through the customer feedback process.There was no request for technical support regarding this allegation and there is no record of a service order being opened.No parts were replaced.The reporter stated there was no malfunction of the device, the medical institution did not request an evaluation of the v60, and that there was no causal relationship between the v60 ventilator and the patient's outcome.The device is back in service at the hospital.Patient circuit ((b)(6)) disposable passive with water trap), humidifier: (b)(6).There was no malfunction of the device.The death was reported to philips through the customer feedback process.G3:(b)(6) 2021.While admitted on (b)(6) 2020, the patient was receiving therapy via the v60 device, the device generated alarms, the patient circuit could have become disconnected from the patient's mask, and the patient experienced an outcome of death.The reporter stated there was no malfunction of the device, the medical institution did not request an evaluation of the v60, and there was no causal relationship between the v60 ventilator and the patient's outcome.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11021254
• MDR Text Key: 221819592
• Report Number: 2031642-2020-04579
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

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?: 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: 12/10/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 08/31/2021
• Supplement Dates FDA Received: 09/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Outcome(s): Death