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

Model Number	V60
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint regarding a v60 device that was operating on battery power even when connected to ac power.It was reported that there was no patient involvement or impact at the time the issue was identified, and the device alarm/alert functioned as intended.The device was evaluated onsite, and testing confirmed the reported issue.Upon inspection, the problem was attributed to a faulty power cord cable.The customer, with assistance from a remote service engineer (rse), confirmed the issue.As a corrective action, the power cord was replaced.Following replacement, the device was retested, and normal operation was restored, with battery voltage and electrical measurements within acceptable limits.The device successfully passed all required performance verification tests per philips standards and was confirmed to meet product specifications before being returned to service.The investigation concludes that no further action is required at this time.If additional information is received, the complaint file will be reopened.Based on the information provided and service performed, it was confirmed that the unit did not meet product specifications at the time of failure.The faulty power cord cable was determined to be the cause of the reported issu.The data entered in this complaint record will be utilized for product quality and safety improvements in accordance with post market surveillance and risk management processes.Root cause: faulty power cord cable resulting in loss of ac power input and unintended operation on battery power.

• Brand Name: RESPIRONICS
• Common Device Name: VENTILATOR, CONTINUOUS USE, 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: 24911549
• Report Number: 2518422-2026-112351
• Device Sequence Number: 9196472
• Product Code: MNT
• UDI-Device Identifier: 00884838020047
• UDI-Public: (01)00884838020047
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: 1053616
• 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: 03/25/2026
• Initial Report FDA Received Date: 04/17/2026
• Date Device Manufactured: 05/06/2010
• 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