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

Model Number	V60
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint from the customer on the v60 ventilator indicating that the device has a boot up failure.It is unknown if the unit was in patient use at the time of the reported issue.There was no patient or user harm reported.
Additional Manufacturer Narrative
It was reported there was no patient involvement at the time the issue was discovered, as the device was in storage.A manufacturer's field service engineer (fse) was dispatched to the site and confirmed the reported problem.The fse powered the unit on and noticed multiple diagnostic codes related to voltage "111b" check vent: 35 v supply failed; "1127" check vent: ovp circuit failed; and "1118" 5 v supply failed.The motor controller (mc) was not reporting as installed.The fse perform the required performance verification tests as required from the service manual, relating to power and the mc not showing up.The fse replaced the original power management (pm) pcba with a replacement and powered up the unit.The ventilator failed with the same codes.At this time the customer stated they would take over and complete the repair.The fse removed the new pm pcba and installed the original pm pcba back into the unit.The customer reported that they replaced the mc pcba and the unit powered on without a failure and resolved the reported problem.The device was returned to service.

• Brand Name: RESPIRONICS
• Common Device Name: 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19320713
• Report Number: 2518422-2024-28268
• Device Sequence Number: 7577402
• Product Code: MNT
• UDI-Device Identifier: 00884838025738
• UDI-Public: 00884838025738
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K102985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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
• Operator of Device: Health Professional
• Device Model Number: V60
• Device Catalogue Number: U1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/26/2024
• Date Device Manufactured: 01/19/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown