MAUDE Adverse Event Report: RESPIRONICS, INC. V60 V60PLUS VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60 V60PLUS VENTILATOR

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Philips received a complaint by the customer on the v60 indicating that while in high flow mode, there is a failure of high flow therapy and alarms when connecting to the pan by the user.It is unknown if the unit was in patient use at the time of the reported issue.No patient or user harm was reported.Investigation is ongoing.

Manufacturer Narrative

Upon further investigation, this case has been downgraded as it was discovered that the reported problem was not device related, because it was verified that the product (high-flow nasal cannula (hfnc) oxygen therapy) associated with the complaint is not a philips device and not a device that philips is a distributor or importer of.This device is out of scope for complaint investigation as it does not constitute a philips device.Therefore, this complaint no longer meets reportability requirements.The v60 device was found to be fully functional; the ventilator was running as expected.There was no problem no malfunction related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the v60 device.

• Brand Name: V60 V60PLUS VENTILATOR
• 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: 18335424
• MDR Text Key: 330604437
• Report Number: 2518422-2023-35839
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• 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: 1137276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/21/2024
• Date Device Manufactured: 03/17/2020
• 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