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 10/31/2023

Event Type  malfunction  

Event Description

Philips received a complaint from the customer, reporting that the v60 ventilator had a burning smell, and visible burn marks on the device.There was no patient involvement when the issue occurred.No patient or user harm reported.A philips remote service engineer (rse) noted that the customer's v60 ventilator had a burning smell, and visible burn marks on the device.The customer reported that occurrence of the issue was observed after the power management (pm) board was previously replaced.Onsite service was requested.

Manufacturer Narrative

A philips service engineer (se) evaluated the device and determined the issue was due to a failure related to the power management (pm) board; however, the repair for the device cannot be conducted at this time, due to a back-order status for the suspected faulty part power management board needed for correction.The material ordered aligns with the recommended repair of the reported malfunction per the service manual.When all parts become available the repairs will be conducted.If new information is received and suggest that the device has additional malfunctions, the record will be reopened, and an investigation will be performed.

Manufacturer Narrative

Insufficient information is available to determine the resolution of the event.The customer refused any additional service from philips, and decided to perform the repairs in house.No further actions were performed by philips, and the case was closed as cancelled.It could not be confirmed if the issue was resolved.No parts were returned for failure investigation.In the event that parts are returned or if new information is provided, the complaint will be reopened to update the investigation.

Manufacturer Narrative

Information was received that the service engineer replaced the motor control board, and the power management board.Additional follow up testing was required.The investigation is ongoing.

• 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: 18216328
• MDR Text Key: 329121642
• Report Number: 2518422-2023-32011
• 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,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,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: Health Professional
• 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: 10/31/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 12/06/2023; 02/23/2024; 02/28/2024
• Supplement Dates FDA Received: 12/07/2023; 03/11/2024; 03/13/2024
• Date Device Manufactured: 07/10/2013
• 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