MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; 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 12/01/2023

Event Type  malfunction  

Event Description

Philips received a complaint from the customer, reporting that the v60 ventilator had a low rate alarm.The device was in clinical use when the issue occurred, the device continued to ventilate.No patient or user harm reported.A philips remote service engineer (rse) noted that the customer's v60 ventilator had a low-rate alarm, that could not be cleared.The customer was informed that a clinical support specialist would reach out for further assistance.Investigation is ongoing.

Manufacturer Narrative

H10: during follow up with the customer, it was reported that there was no patient involvement with the device.No patient or user harm reported.The customer also reported that the clinical support team had contacted the customer, and that the event was only for educational purposes.The customer reported that there was no problem, but that then answered that the device has not been returned to service.An additional follow up was performed with the customer for clarification; however, no response was provided.In the event that new information becomes available, the complaint will be reopened, and the investigation will be updated.

• 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: 18304575
• MDR Text Key: 330194089
• Report Number: 2518422-2023-34775
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 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
• 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: 12/01/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/18/2024
• Date Device Manufactured: 01/02/2021
• 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