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

Model Number V60 PLUS VENTILATOR, US

Device Problem Gas/Air Leak (2946)

Patient Problems Dyspnea (1816); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2022

Event Type  Injury  

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

The investigation is ongoing.

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.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.During this event, there was a mild change in the patient¿s clinical condition.This was not life-threatening, nor did it result in permanent impairment.However, if the nurse and respiratory therapist had not intervened, it is possible that the patients condition could have deteriorated further.It is also possible that there could have been additional clinical consequences related to the ¿burning smell.¿ therefore this meets criteria for serious injury.

Manufacturer Narrative

This report is being submitted as a correction in response to corrective actions taken by the legal manufacturer.The manufacturer site number was incorrectly selected resulting in incorrect report numbers.A new mdr with the correct manufacturer site selected has been submitted under manufacturer report # 2518422-2023-19082.

• Brand Name: RESPIRONICS
• Type of Device: V60-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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16087718
• MDR Text Key: 308589133
• Report Number: 2031642-2023-00012
• 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,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: 01/03/2023
• Supplement Dates Manufacturer Received: 01/01/2023; 01/01/2023
• Supplement Dates FDA Received: 01/30/2023; 08/09/2023
• 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