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

Model Number V60

Device Problem Gas/Air Leak (2946)

Patient Problem Dyspnea (1816)

Event Date 12/02/2022

Event Type  malfunction  

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 customer, reporting that the v60 ventilator had a low leak - co2 rebreathing risk error.The device was in clinical use when the issue occurred.It was reported that the patient complained about not receiving enough air from device, it was t also stated, there was a burning smell.The patients spo2 was in the lower 90's when it was previously in the mid to high 90's.It was reported that a red alarm was continuously appearing.When the respiratory therapy contact arrived to the room, they noticed that the device was displaying a "low leak - co2 rebreathing risk" alarm.It was confirmed that the patient was doing okay, but that they felt that the machine was not providing enough air, and that there is a burning smell coming from the mask.The device was immediately replaced with a different v60 ventilator.After changing to the new v60 ventilator (new mask with the exact same settings), the patient stated that it felt a lot better and they did not notice a burning smell.During evaluation of the suspected device, the biomed noticed that the filter on the back was clogged with a lot of dust and there was a slight burnt smell coming from the machine.Investigating is ongoing.

Manufacturer Narrative

It was determined this report is a duplicate of mfr report number: 2031642-2023-00012.Therefore the investigation will be addressed through that record.

• 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: kimberly shelly ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 16075895
• MDR Text Key: 307785487
• Report Number: 2031642-2022-03272
• 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: Health Professional
• Reporter Occupation: Biomedical Engineer
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/03/2023
• Supplement Dates FDA Received: 01/23/2023
• 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