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

Model Number V60 V60PLUS VENTILATOR

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 11/08/2023

Event Type  malfunction  

Event Description

Philips received a complaint from the customer, reporting that the v60 ventilator had a display that failed.It was unknown how the issue was found.No patient or user harm reported.A philips remote service engineer (rse) noted that the customer's v60 ventilator had a display that failed.The investigation is ongoing.

Manufacturer Narrative

A philips service engineer (se) evaluated the device and confirmed the customer's issue.It was noted that the device operates, and the touchscreen works, but remained dark.The se noted that the liquid crystal display (lcd) cable, and user interface (ui) board to lcd cable was replaced, but the replacements did not resolve the issue.The se noted that an lcd assembly would be requested but was on backorder.Due to the replacement part lcd being on backorder, the repair for the device cannot be conducted at this time.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.

Manufacturer Narrative

Additional details were documented in a follow up record, and it was noted that the issue was found during clinical use.There was no adverse outcome to the patient care or therapy reported.The device was removed from service.A service engineer (se) reported that the user interface assembly was replaced to resolve the issue.The system meets the specification for the performed service and is returned to use.

Manufacturer Narrative

A service engineer (se) was dispatched and reported that the issue was confirmed while evaluating the device.The se reported that the following parts were replaced, user interface (ui) to liquid crystal display (lcd) cable, lcd screen, lcd cable, and back light inverter board.The se reported that replacing all four parts did not resolve the issue.Additional follow up is required.

• 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: 18237717
• MDR Text Key: 329374159
• Report Number: 2518422-2023-32667
• 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,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: 11/08/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 11/30/2023; 02/27/2024; 02/26/2024
• Supplement Dates FDA Received: 12/12/2023; 03/04/2024; 03/13/2024
• Date Device Manufactured: 07/05/2017
• 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