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

Model Number V60

Device Problem Failure to Deliver (2338)

Patient Problems Unspecified Vascular Problem (4441); Unspecified Respiratory Problem (4464); Insufficient Information (4580)

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

E: (b)(6) hospital china phone: (b)(6).

Event Description

Philips received a complaint from the customer reporting that the v60 ventilator had an oxygen leak.The patient was noted to have unstable vital signs (unspecified), and a decrease to saturation of peripheral oxygenation (spo2) to an unspecified extent.The ventilator was immediately replaced, and the patient's condition was noted to have improved.Investigation ongoing.

Manufacturer Narrative

A follow up was performed with the key market, and the responder reported that no medical intervention was required, but there was a delay in therapy, and the patient was moved to a different ventilator.It was reported that the patient was (b)(6) years old.No injuries were reported.The responder reported that the gas delivery system was repaired by the hospital's equipment department.The device was restored to normal use, and the device was returned to service.No parts were reported to have been replaced, and the responder did not specify what repair was performed on the gas delivery system.

• 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: 18970690
• MDR Text Key: 338509146
• Report Number: 2518422-2024-15066
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: 00884838025776
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/08/2024
• Date Device Manufactured: 09/26/2019
• 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
• Patient Age: 72 YR