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

Model Number V60

Device Problem No Flow (2991)

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

Event Date 08/24/2023

Event Type  malfunction  

Event Description

Philips received a complaint from the customer, reporting that the v60 ventilator was not showing the tidal volume.There was no patient involvement when the issue occurred.No patient or user harm reported.A philips remote service engineer (rse) noted that the customer's v60 ventilator was not showing the tidal volume.It was recommended to replace the gas delivery system (gds).It was also recommended to perform the following: perform self-test, check the error log, and evaluate the motor control and gas delivery system.

Manufacturer Narrative

E1 reporter phone number - (b)(6).

Manufacturer Narrative

Insufficient information is available to determine the resolution of the event.Multiple good faith efforts (gfe) were performed for further details regarding the event; however, no response was provided.It could not be determined if the customer's issue was resolved or if the device had been repaired.No parts were returned for failure investigation.In the event that parts are returned or if new information is provided, the complaint will be reopened to update the investigation.

• 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: 17683906
• MDR Text Key: 322646548
• Report Number: 2518422-2023-21726
• 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,User Facility
• 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: Other
• Device Model Number: V60
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 10/04/2023
• Supplement Dates FDA Received: 10/05/2023
• Date Device Manufactured: 03/08/2021
• 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