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

Model Number V60

Device Problem Failure to Sense (1559)

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

Event Date 02/27/2024

Event Type  malfunction  

Event Description

Philips received a complaint from the biomedical engineer (bme) on the v60 ventilator indicating that the device was not going into standby mode.It was reported that there was no patient involvement at the time the issue was discovered.There was no report of patient or user harm.The remote service engineer (rse) performed troubleshooting with the bme and had the bme check the average air slpm (standard liter per minute) in service mode.The bme stated that it was showing -1.5slpm when set to 0.The rse informed the bme that this is triggering the device to back out of standby mode.The rse advised the bme that the manufacturer's recommendation is to replace the flow sensor assembly and provided the bme with the part number and price of the replacement flow sensor assembly for repair.

Manufacturer Narrative

Per a good faith effort response received, the bme stated that a new flow sensor assembly was purchased.The biomedical engineer installed the new flow sensor assembly, and it was confirmed that the issue was resolved.The device passed the required performance verification tests per philips standard and was returned to service.

• 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: 18925012
• MDR Text Key: 337918633
• Report Number: 2518422-2024-14209
• 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
• 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: Other
• Device Model Number: V60
• Device Catalogue Number: 1138747
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 03/22/2024
• Date Device Manufactured: 01/04/2021
• 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