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

Model Number	V60
Medical Device Problem Code	Failure to Run on Battery (1466)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint from the customer, reporting that the v60 ventilator's battery voltage failed, and the device failed to power on correctly.There was no patient involvement when the issue occurred.There was no patient or user harm reported.A philips remote service engineer (rse) noted that the v60 ventilator's battery failure caused the device to fail to power on correctly.The customer ordered a replacement battery.
Additional Manufacturer Narrative
The replacement of the battery aligns with the recommended repair of the reported malfunction per the service manual.The material has already been requested and ordered.The repair of the unit cannot be completed at this time due to the battery being on back order without estimated time of availability.When the part becomes available the repairs will be completed.If new information is received and suggests that the device has additional malfunctions, the record will be reopened, and further investigation will be performed.

• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 22593746
• Report Number: 2518422-2025-048345
• Device Sequence Number: 9087922
• Product Code: MNT
• UDI-Device Identifier: 00884838009844
• UDI-Public: (01)00884838009844
• Combination Product (Y/N): N
• Initial Reporter Country: UP
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2025

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
• Operator of Device: Other
• Device Model Number: V60
• Device Catalogue Number: 1053613
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/04/2025
• Date Device Manufactured: 09/16/2020
• 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