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

Model Number V60

Device Problem Decrease in Pressure (1490)

Patient Problem Insufficient Information (4580)

Event Date 10/11/2023

Event Type  Death  

Event Description

Philips received a complaint by the customer on the v60 indicating that while in clinical use, the device alarmed for low o2 pressure.It was reported that the patient passed away.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.The ventilator is being sequestered at the hospital until determination is made on who will evaluate the ventilator.Onsite repair is pending.Additional information regarding the reported event has been requested.

Manufacturer Narrative

The manufacturer's field service engineer (fse) was dispatched to the site and confirmed that the device is not detecting o2 incoming from the source.The o2 tank was empty upon arrival at the site.All tests passed.It was determined that the reported problem was not device related.The v60 device was found to be fully functional; the ventilator was running as expected.The reported event was caused by user error and the empty o2 tank.

• 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: 17987847
• MDR Text Key: 326305150
• Report Number: 2518422-2023-27606
• 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: Other Health Care Professional
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/07/2023
• Date Device Manufactured: 06/26/2017
• 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
• Patient Outcome(s): Death