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 01/27/2024

Event Type  malfunction  

Manufacturer Narrative

E1: (b)(6).

Event Description

Philips received a complaint by the customer on the v60, indicating that the device was getting a near-end pressure sensor error message on the display.The device was in use on a patient at the time the reported issue was discovered; however, there was no harm to the patient or user.No medical intervention provided to the patient, nor a delay was noted.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.The rse recommended troubleshooting and replacement of data acquisition (da) board and the flow sensor assembly.

Manufacturer Narrative

H10: it was reported there was no patient involvement at the time the issue was discovered.The authorized service provider (asp) evaluated the device and confirmed that the machine and proximal pressure sensor autozero failed message appeared after it was turned on and that the device cannot work normally.After reconnecting the power cord, the machine is turned on, and the fault remains.It has been determined that the gas delivery system (gds) needs to be replaced.The asp replaced the gds to resolve the reported issue.The device passed required performance verification tests per philips standards and was returned to service.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.Based on information provided and/or service performed it has been confirmed unit did not meet product specifications.It was determined that the gds was the cause of the reported issue.The device was not being used for treatment when the reported event occurred.

• 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: 18622517
• MDR Text Key: 334320812
• Report Number: 2518422-2024-05440
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: (01)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: Health Professional
• Device Model Number: V60 V60PLUS VENTILATOR
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/07/2024
• Date Device Manufactured: 03/25/2021
• 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