MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; V60-VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60 PLUS VENTILATOR, US

Device Problem Gas/Air Leak (2946)

Patient Problem Dyspnea (1816)

Event Date 12/06/2022

Event Type  Injury  

Manufacturer Narrative

H10: the biomed reported that the cooling fan was replaced and a full preventative maintenance was performed and the device passed testing.The device was returned to use.H11: upon further review of the reported event, it was determined that a duplicate complaint was reported under mfr report number 2031642-2022-03272.The duplicate case had information that meet the criteria for serious injury.All information from the case reported in mfr report number 2031642-2022-03272 was transferred to this case.This report is being submitted as part of a corrective action to replace manufacturer report # 2031642-2023-00012 all information from the original report(s) has been transferred to this report.

Event Description

This report is based on information provided by philips service personnel and has been investigated by the philips complaint handling team.Philips received a complaint from the customer, reporting the that v60 ventilator displayed a low leak co2 rebreathing risk alarm the device was in clinical use when the issue occurred; the customer was moved to a different ventilator.No patient or user harm reported.A review of the risk management file was performed and it was determined that this complaint is a reportable malfunction.Regulatory reports have been submitted per regulations.A philips remote service engineer (rse) reported that during evaluation with the customer, the device turned on as expected, no check vent or vent inoperable alarms were displayed.It was noted that the device would transfer from ac to dc power as expected.The customer stated that they reviewed the diagnostic page, and nothing unexpected was scene.The customer then stated that the sulfur smell seemed to be isolated to the power supply.The rse advised the customer to remove the power supply and check if the smell followed instead of being inside the ventilator.The rse then advised the customer to perform a visual inspection on all electrical components, and to look for any signs of overheating.If it was determined that the smell came from the power supply, that the customer replace the power supply; however, if the smell came from the ventilator, it was advised to check the other components for the source of the smell.The rse advised the customer that the issue came of the power management (pm) pcba, that the rse should be informed in order to have device evaluated by a field service engineer (fse).It was then noted that once the odor issue identified and resolved, that the customer should perform a full pvt and address any issues that may have caused the low leak alarm.During a follow up with the customer, it was reported that the customer removed the pm pcba, power supply, motor controller (mc) pcba, and the cooling fan.After isolating the components, it was determined that the cooling fan had produced the overheating / sulfur smell.It was then reported that the customer would replace the cooling fan and will perform a full successful pvt before placing it back into service.

Manufacturer Narrative

This report is being filed as a correction.Box b: adverse event/outcomes attributed were corrected on this report.

• Brand Name: RESPIRONICS
• Type of Device: V60-VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17487848
• MDR Text Key: 320675493
• Report Number: 2518422-2023-19082
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• 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 PLUS VENTILATOR, US
• Device Catalogue Number: 1138747
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 12/06/2022
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/03/2021
• 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