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

Model Number	V60
Medical Device Problem Code	Grounding Malfunction (1271)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint by the customer on the v60 indicating that an electrical safety test failure occurred.It was reported there was no patient involvement at the time the issue was discovered.It was discovered at bench repair that an electrical safety test failure occurred.The bench service engineer (bse) confirmed that the power cable and power cord both had more resistance than allowed in the electrical tests.The bse determined a replacement of both the power cable and cord was required.Device evaluation and repair are pending.
Additional Manufacturer Narrative
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Additional Manufacturer Narrative
The bse replaced the power cord to resolve the reported issue.The device passed required performance verification tests per philips standards and was 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.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.

• 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: 24914744
• Report Number: 2518422-2026-112368
• Device Sequence Number: 9241976
• Product Code: MNT
• UDI-Device Identifier: 00884838009851
• UDI-Public: (01)00884838009851
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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
• 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: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053614
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/01/2026
• Date Device Manufactured: 03/11/2015
• 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