MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC 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 07/13/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 24jul2020.

Event Description

A customer reported to philips that a patient experienced an outcome of death while receiving therapy from a respironics v60 ventilator.The customer reported that the unit was in use on a patient at the time of the outcome.

Manufacturer Narrative

G4: 04sep2020, b4: 04sep2020.The customer evaluated the device with assistance from a remote philips service engineer, which included a review of the diagnostic report (drpta) and verification that the device alarms were working as intended.No parts were replaced.The device passed all performance assurance tests and was placed back into use with the customer.This reporter stated that a female patient of unknown age, height, and weight was admitted to a hospital on an unknown date with the admitting diagnosis not reported.Relevant past medical history included do not resuscitate orders.No relevant past drug history or relevant concomitant medical products were reported.On an unknown date while admitted, the patient was prescribed ventilation therapy via the respironics v60 ventilator, device mode, configuration, settings, patient circuit, and patient interface not reported.While admitted on (b)(6) 2020, the patient experienced an outcome of death while receiving ventilation therapy via the v60 ventilator, software version 2.10.No cardiopulmonary resuscitation efforts were reported.No relevant laboratory data was reported.Hospital staff reported that the patient had been "declining" prior to the event and outcome.There was no allegation that the patient's outcome was associated with the use of the device.Review of the provided diagnostic report (drpta) from 13jul2020, showed that the device was in use at 02:01:47 am, was set for bi-level positive airway pressure mode, several high rate, patient disconnect, low minute ventilation, high tidal volume, low tidal volume, and low inhalation pressure alarms were generated.There is no information to support that a malfunction occurred.The device was behaving as intended when it alerted the users to various alarm conditions.The hospital's biomedical engineer reported that there was no fault with the device.There was no allegation that the patient's outcome was associated with the use of the device.The device was in use on a patient with dnr orders who was in "declining" health.No parts were returned to failure investigation; therefore, the reported issue's root cause could not be determined.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: 10323436
• MDR Text Key: 200379483
• Report Number: 2031642-2020-02483
• 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: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• 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: 07/21/2020
• 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