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

Model Number V60

Device Problem Excessive Heating (4030)

Patient Problem Cardiac Arrest (1762)

Event Date 04/13/2021

Event Type  Injury  

Event Description

It was reported to philips that while delivering therapy to a patient, the respironics v60 ventilator device generated a blower temperature too high alarm, over heated, and entered into an inoperable state.The customer reported that the unit was in use on a patient at the time of the reported device symptom and adverse event.A philips field service engineer (fse) was dispatched to the customer site and determined that the blower required replacement.No diagnostic report (drpt) was provided for review.The fse replaced the blower assembly to resolve the issue.The device passed performance verification testing after repair was completed and was returned to service.This reporter stated that a patient of unknown age, gender, height, and weight was admitted to a hospital on an unknown date with an admitting diagnosis of coronavirus (covid19).Relevant medical history included multiple co-morbidities.No relevant past drug history or relevant concomitant medical products were reported.While admitted on an unknown date, the patient was prescribed average volume-assured pressure support (avaps) therapy via the respironics v60 ventilator; 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, the device generated a blower temperature too high alarm, shut down, the patient experienced a cardiopulmonary arrest, cardiopulmonary resuscitation efforts were initiated, the patient experienced a return of spontaneous circulation, was then intubated and placed on mechanical ventilation; brand, model, and prescription not reported.Days later on an unknown date, the patient experienced an outcome of death due to their multiple co-morbidities.The cause of death was not reported.There was no allegation against the v60 ventilator and the patient¿s outcome.There were no curtains, drapes, or other materials on the v60 ventilator at the time of the device behavior.No relevant laboratory data was reported.

Manufacturer Narrative

The alleged malfunctioned blower motor was received by philips failure investigations and inspected/evaluated.Upon further evaluation, it was determined that the customer complaint could not be verified and that the returned blower motor passed all testing with no fault found.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 11813908
• MDR Text Key: 250368630
• Report Number: 2031642-2021-03696
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/13/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2021
• Supplement Dates Manufacturer Received: 10/14/2021
• Supplement Dates FDA Received: 03/10/2022
• Date Device Manufactured: 06/17/2020
• 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
• Patient Outcome(s): Required Intervention