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

Model Number V60 V60PLUS VENTILATOR

Device Problems Failure to Power Up (1476); No Flow (2991)

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

Event Date 11/08/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that the device had a power issue upon powering on.It was reported there was no patient involvement at the time the issue was discovered.Investigation is ongoing.

Manufacturer Narrative

H10: follow up.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.The authorized service provider (asp) reported that they are not seeing the air and o2 information on the vent info screen.The asp did not test the unit, but it was noted that it seems to be running fine.The asp stated the cable is good and properly connected to the da pcba.The rse recommended to replace the gds and provided parts id.Investigation remains ongoing.

Manufacturer Narrative

H10: the fse replaced the gas delivery system (gds) to resolve the reported issue.The device passed required performance verification tests per philips standards.However, the customer seen the unit and wanted to run the pvt again.During the pvt, the unit failed the leak test.Further troubleshooting was performed, and it was observed that there were additional issues.The boots and white clamps were not installed properly, damage to the pins, boots, o-rings and grommets.The additional issues, troubleshooting and repair will be addressed in separate cases and investigated by the philips complaint handling team.

• 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: 18174380
• MDR Text Key: 328571394
• Report Number: 2518422-2023-31154
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 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
• Reporter Occupation: Biomedical Engineer
• 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?: No
• Is this a Product Problem Report?: Yes
• 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: 11/20/2023
• Supplement Dates Manufacturer Received: 11/28/2023; 12/21/2023
• Supplement Dates FDA Received: 12/14/2023; 01/08/2024
• Date Device Manufactured: 04/25/2013
• 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