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

Model Number	V60
Medical Device Problem Codes	Unstable (1667); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Philips received a complaint by the customer on the v60 indicating that the device fell.It was reported there was no patient involvement at the time the issue was discovered.It was reported that the device fell.The customer reported that the end cap was missing after the fall.The remote service engineer (rse) provided the customer with the part number of the end cap for the customer to order and replace.Device evaluation and repair are pending.
Additional Manufacturer Narrative
Philips received a complaint by the customer on the v60 indicating that the device fell.It was reported there was no patient involvement at the time the issue was discovered.It was reported that the device fell.The customer reported that the end cap was missing after the fall.The remote service engineer (rse) provided the customer with the part number of the end cap for the customer to order and replace.A quote was sent to the customer for the part but later expired.No further action provided.A quote was sent to the customer for the part but later expired.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 22124486
• Report Number: 2518422-2025-046309
• Device Sequence Number: 8678542
• Product Code: MNT
• UDI-Device Identifier: 00884838009868
• UDI-Public: (01)00884838009868
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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
• Device Catalogue Number: 1053615
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/22/2025
• Date Device Manufactured: 07/20/2010
• 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