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

Model Number	V60
Medical Device Problem Codes	Failure to Charge (1085); Failure to Run on Battery (1466)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint from the service engineer (se), reporting that the v60 ventilator had a battery that was non-functional.There was no patient involvement when the issue occurred.No patient or user harm reported.A philips service engineer (se) reported that the v60 ventilator had a battery that was non-functional.The se noted that the battery would need to be replaced.Investigation ongoing / resolution pending.
Additional Manufacturer Narrative
E:(b)(6).
Additional Manufacturer Narrative
Insufficient information was available to determine the resolution of the event.The work order for repair was cancelled, and the record was closed with no further actions performed by philips.No further details could be obtained regarding the event, and it could not be determined if the customer's issue was resolved or if the device had been repaired.No parts were returned for failure investigation.In the event that parts are returned or if new information is provided, the complaint will be reopened to update the investigation.
Additional Manufacturer Narrative
Additional details were provided, and it was clarified that the battery would not hold a charge or allow the device to operate in battery mode if the alternating current (ac) power cord is not connected.The customer was provided with a quote for evaluation/repair.
Additional Manufacturer Narrative
Insufficient information was available to determine the resolution of the event.A quote was provided to the customer; however, the quote expired, and the record was closed with no further actions performed by philips.No further details could be obtained regarding the event, and it could not be determined if the customer's issue was resolved or if the device had been repaired.No parts were returned for failure investigation.In the event that parts are returned or if new information is provided, the complaint will be reopened to update the investigation.

• 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: 21575296
• Report Number: 2518422-2025-031919
• Device Sequence Number: 8347191
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/01/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 03/13/2025; 04/27/2025; 04/25/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 03/24/2025; 04/15/2025; 05/01/2025
• Date Device Manufactured: 02/01/2011
• 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