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

Model Number	V60 V60PLUS VENTILATOR
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the v60 ventilator indicating that there was a low leak co2 rebreathing alarm.It is unknown if the device was in use at the time of the reported problem.No patient or user harm reported.The customer accepted a proposal for onsite service by a field service engineer (fse) and a replacement flow sensor assembly (fsa).This investigation is ongoing.
Additional Manufacturer Narrative
In a good faith effort (gfe) response from the customer received on 12 aug 2024, it was provided that the device issue occurred outside of clinical use, with no patient involvement.This investigation is ongoing.
Additional Manufacturer Narrative
On 29jan2025 the field service engineer (fse) returned to the customer site and replaced the gas delivery system (gds).Following the part replacement, the fse completed a performance verification test.The device passed the pressure, air, and flow tests.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Additional Manufacturer Narrative
H10: on 11jan2025, a field service engineer (fse) went to the customer site and attempted to return the device to full functionality by replacing the flow sensor assembly (fsa), but the fse determined that a replacement gas delivery system (gds) would be required.Further service, troubleshooting, and part replacement is pending.The investigation is ongoing.

• 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: 19960396
• Report Number: 2518422-2024-50647
• Device Sequence Number: 15247324
• Product Code: MNT
• UDI-Device Identifier: 00884838025738
• UDI-Public: (01)00884838025738
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup,Followup
• Report Date (Section B): 01/30/2025

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 Model Number: V60 V60PLUS VENTILATOR
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 08/12/2024; 01/11/2025; 01/29/2025
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 08/13/2024; 01/23/2025; 01/30/2025
• Date Device Manufactured: 01/30/2017
• 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