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

Model Number V60 V60PLUS VENTILATOR

Device Problem Device Sensing Problem (2917)

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

Event Date 12/08/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60, indicating that while the device was in standby, when mask is put back on patient, the device did not automatically come out of standby.The respiratory therapist (rt) had to manually get it out of standby.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.The device was swapped out with a different device.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 customer states that the device comes out of standby when he applies some proximal pressure.The rse advised to perform a full performance verification test (pvt) and address any issues found.Advised of possible flow or pressure issue.

Manufacturer Narrative

E1: reporting address state: (b)(6).Reporting address postal: (b)(6).Reporting institution phone #: (b)(6).Reporter phone #: (b)(6).

Manufacturer Narrative

H10: after further troubleshooting, the customer conducted a performance verification on the v60 and concentrated on the flow and pressure verifications, and it was confirmed that the performance verification passes.The remote service engineer (rse) stated the most likely the issue can arise from an excessive leak like from a beard or the inability unable to trigger a breath from a weak patient.No fault was able to be replicated.The customer conducted the required performance verification tests per philips standards and passed 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 not determined what the cause of the reported issue was.Was unable to replicate the reported issue.The device was being used for treatment when the reported event occurred.No patient or user harmed.

• 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: 18310183
• MDR Text Key: 330278311
• Report Number: 2518422-2023-35006
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• 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: 1053614
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 12/15/2023
• Supplement Dates FDA Received: 12/18/2023
• Date Device Manufactured: 12/09/2014
• 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