MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VS2+ NBP/SPO2

Model Number	863278
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.Section e reporting institution phone #: (b)(6).Section e reporter phone #: (b)(6).
Event or Problem Description
It was reported that the device has a faulty speaker, and the speaker was completely out of sound.The device was in use on a patient at the time of the event.There was no adverse event reported.
Additional Manufacturer Narrative
Diagnostic/functional testing was performed at the philips authorized repair facility.Results of functional testing indicate that the device speaker was defective and needed to be replaced.A repair quote was sent to the customer to replace the faulty speaker.The quote expired.The device will be returned unrepaired.Based on the information available, the cause of the reported problem was the speaker.The reported problem was confirmed.The customer was provided with a quote for a replacement speaker.The quote expired and the device will be returned unrepaired.The investigation concludes that no further action is required at this time.If additional information is received a supplemental report will be sent.

• Brand Name: SURESIGNS VS2+ NBP/SPO2
• Common Device Name: SURESIGNS VS2+ NBP/SPO2
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 21651799
• Report Number: 1218950-2025-000176
• Device Sequence Number: 7489517
• Product Code: DXN
• UDI-Device Identifier: 00884838028395
• UDI-Public: (01)00884838028395
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K112652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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: Health Professional
• Device Model Number: 863278
• Device Catalogue Number: 863278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 09/14/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2018
• 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