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

Model Number V60 V60PLUS VENTILATOR

Device Problem Failure to Sense (1559)

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

Event Date 02/05/2024

Event Type  malfunction  

Event Description

Philips received a complaint on the v60 ventilator, indicating that the device was producing a patient disconnect alarm when the patient was not disconnected.The device was reported to be in use at the time of the reported problem.No patient or user harm reported.The customer informed the biomedical engineer (bme) of the issue.The bme stated that they were unable to duplicate the issue on (b)(6) 2024.The bme ran leak tests and then connected the device to a test lung and did not get any alarms.The bme stated that they suspected the reported patient disconnect alarms were due to bad tubing or connection on the patient side of the circuit.This investigation is ongoing.

Manufacturer Narrative

H10: in a good faith effort (gfe) response from the biomedical engineer (bme) received on 13feb2024, it was confirmed that the patient disconnects alarms first occurred on 02feb2024.The device was confirmed to have been returned to use and no further device issue has occurred since the bme's evaluation of the device on 07feb2024.The bme stated that the patient information from the time of the event was asked but unknown.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: 18697185
• MDR Text Key: 335343264
• Report Number: 2518422-2024-07146
• 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,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: 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: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 02/14/2024
• Date Device Manufactured: 01/30/2017
• 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