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

Model Number V60 V60PLUS VENTILATOR

Device Problem Output Problem (3005)

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

Event Date 07/19/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that the air flow sensor failed.It is unknown at this time if the unit was in patient use at the time of the reported issue.No patient or user harm was reported.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.The customer called in to report that their air flow sensor failed.Onsite service is currently pending.

Manufacturer Narrative

The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.The customer called in to report that their air flow sensor failed.A quote was sent to the customer but later cancelled after 30 days with no response from the customer.No work was performed by philips.A quote was sent to the customer but later cancelled after 30 days with no response from the customer.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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 17482165
• MDR Text Key: 321227700
• Report Number: 2518422-2023-18895
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)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,User Facility
• Reporter Occupation: Biomedical Engineer
• 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 V60PLUS VENTILATOR
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 08/20/2023
• Supplement Dates FDA Received: 08/22/2023
• Date Device Manufactured: 10/04/2016
• 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