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 01/09/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted as part of a corrective action to replace manufacturer report #2031642-2023-00410.All information from the original report(s) has been transferred to this report.

Event Description

Philips received a complaint by the customer on the v60 indicating that a "o2 device failed" error code was displayed.It was reported that there was no patient involvement at the time the issue was discovered.The customer replaced the oxygen solenoid valve, and the reported issue was resolved.The investigation concludes that no further action is required at this time.

• 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: 17435400
• MDR Text Key: 320143458
• Report Number: 2518422-2023-17789
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838089297
• UDI-Public: (01)00884838089297
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,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: 1137292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/23/2019
• 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