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

Model Number	V60
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the v60 ventilator indicating that the device had unexpectedly turned off during a test run.The device was reported to be outside of use at the time of the reported problem.There was no patient or user harm reported.The customer stated that, during a test run, an unknown alarm sounded and then the device turned off, then the device recovered on its own.The device was replaced with another unit so that it could be taken to a service center to be evaluated by an authorized service provider (asp).An asp evaluated the device but was unable to reproduce the issue.The asp checked the device's event log and found that the code for a check vent: ventilator restarted alarm, 1101, was logged.This occurred in conjunction with a diagnostic code 3007.Per the v60 service manual, error 1101 indicates that the ventilator restarted due to anomalies detected during operation.This could include invalid or corrupted information, unanticipated situations, or object allocation errors.The customer was informed that if diagnostic code 1101 occurs in conjunction with diagnostic code 3007 (software exception), no action is required.With no action being required for these two codes, the customer requested that the device be returned without further service.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened, a supplemental report will be submitted.

• 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: 25058387
• Report Number: 2518422-2026-112829
• Device Sequence Number: 9399475
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: (01)00884838033832
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2026

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: 1076709
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/01/2026
• Date Device Manufactured: 05/22/2019
• 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