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

Model Number V60

Device Problem Obstruction of Flow (2423)

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

Event Date 11/15/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60, indicating that the device was getting patient circuit occluded alarm message.It was reported there was no patient involvement at the time the issue was discovered.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed the reported problem.While troubleshooting, it verified that the blower was not spinning at all.It was recommended to replace the blower, then the motor controller (mc) printed circuit board assembly (pcba).

Manufacturer Narrative

H10: the customer replaced the blower assembly and the motor controller (mc) printed circuit board assembly (pcba) 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 blower assembly and the mc pcba board was the cause of the reported issue.The device was not being used for treatment when the reported event occurred.Although requested, the defective parts were not received at this time.A supplemental report will be submitted if the part is received and evaluated.

• 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: 18229438
• MDR Text Key: 329266817
• Report Number: 2518422-2023-32398
• 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: 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
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 12/15/2023
• Date Device Manufactured: 11/26/2012
• 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