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 07/18/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that the flow was out of range.It is unknown 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 the flow was out of range.A quote for onsite service was sent to the customer.

Manufacturer Narrative

Quote for service was cancelled due to no response from the customer.No work was performed by philips.The complaint will be processed for closure.If additional information becomes available at a later date, or if the customer eventually decides to have the device repaired, the complaint will be reopened, and a supplemental report will be submitted.

Manufacturer Narrative

A field service engineer (fse) went onsite and confirmed the reported issue.The fse replaced the flow sensor to resolve the reported issue.The device passed required performance verification tests per philips standards and was returned to service.

• 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: 17411959
• MDR Text Key: 320171260
• Report Number: 2518422-2023-17281
• Device Sequence Number: 1
• Product Code: MNT
• 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
• Type of Report: Initial,Followup,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: 1138747
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 07/28/2023
• Supplement Dates Manufacturer Received: 08/23/2023; 09/29/2023
• Supplement Dates FDA Received: 08/29/2023; 10/04/2023
• Date Device Manufactured: 10/13/2021
• 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