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

Model Number V60 V60PLUS VENTILATOR

Device Problem Device Emits Odor (1425)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60, indicating that while setting up the device, there was a burning smell, and the device alarmed.It was reported that there was no patient involvement at the time the issue was discovered.The customer reported to the remote service engineer (rse) that while setting up the device, there was a burning smell, and the device alarmed.The customer also informed the rse that the biomedical engineer (bme) could not duplicate the issue as there was no evidence of a burning smell.The customer requested assistance with troubleshooting, and the rse advised the customer to perform visual inspection for traces of burnt components on the power supply, power management (pm) printed circuit board assembly (pcba), central processing unit (cpu) pcba, and internal display parts.The rse also advised the customer to not swap the user interface (ui) assembly for testing and to check j1 on the pm pcba orange/brown wire for 24vdc.The customer followed up with the rse and verified that there were not any burnt components that were visible within the device.

Manufacturer Narrative

H10: multiple attempts have been made on 06nov2023, 16nov2023, and 28nov2023 to try to obtain further information about this issue, but no response was received from the customer.This file is closed and can be reopened if new information becomes available.

• Brand Name: RESPIRONICS
• Type of Device: 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18092224
• MDR Text Key: 327627987
• Report Number: 2518422-2023-29438
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• 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,User Facility
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/08/2023
• Date Device Manufactured: 05/02/2017
• 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