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

Model Number V60

Device Problem Improper Flow or Infusion (2954)

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

Event Date 12/06/2022

Event Type  malfunction  

Event Description

This report is based on information provided by philips, remote service personnel and has been investigated by the philips complaint handling team.Philips received a complaint by the customer on the v60 indicating that the device is giving out wrong values or volumes.Caller wants to know what the reported issue means.The device was in use on a patient at the time the reported issue was discovered; however, there was no harm to the patient or user.The device was swapped out with a different device.No medical intervention provided to the patient nor a delay was noted.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.The rse advised that the rt was seeing values or volumes as delivered to the patient that were not what was expected.Advised more information from rt would be needed as to the specific issue was.Advised that no matter what the issue, that performing a full pvt would diagnose the problem or if there was a problem.Provided manual reference and discussed required test equipment and the service kit.Provided manual reference to the pvt and discussed.Resolution and disposition are pending - investigation on going.

Manufacturer Narrative

Per gfe response, the biomed customer called into philips tech support to get a better understanding of the issue, did not do any further investigation nor any repair to the device, just called in for information.No further information was able to be obtained.This report is being submitted as part of a corrective action to replace manufacturer report # 2031642-2023-00006.All information from the original report(s) has been transferred to this report.

• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17410811
• MDR Text Key: 320241942
• Report Number: 2518422-2023-17254
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 07/27/2023
• Date Device Manufactured: 05/15/2019
• 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