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

Model Number V60

Device Problem Increase in Pressure (1491)

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

Event Date 01/23/2023

Event Type  malfunction  

Event Description

Philips received a complaint on the v60 ventilator, indicating that the high flow pressure safety triggered due to canula use.It is unknown if the device was in use at the time of the reported problem.No patient harm reported.The remote service engineer (rse) provided the customer with information.The rse stated that no additional information was available.Per the cancellation reason field entered into the remote service work order of the salesforce servicemax case stating that no additional information was available, it is unknown if the device was in or out of use at the time the high flow issue was found.The rse entered into the case closure reason field of the salesforce case that no further work was performed by philips.The front bezel was replaced and the reported issue was resolved.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

Per remote service engineer the work order was canceled after the rse confirmed the customer was not reporting a failure of the device, merely requesting information.As there was no device issue, it is considered that the device is out of use.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 16403795
• MDR Text Key: 309866260
• Report Number: 2518422-2023-05161
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• 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: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2023
• Date Device Manufactured: 12/10/2015
• 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