MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VS4; SURESIGNS VS4 NBP, SPO2

Model Number	863283
Medical Device Problem Codes	No Audible Alarm (1019); No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (b)(6).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.
Event or Problem Description
The customer requested a replacement speaker.It is unknown if the device produced sound at the time of the report.It is unknown if the device was in use at time of event, and there was no adverse event reported.
Additional Manufacturer Narrative
A philips remote service personnel (rsp) interviewed the customer who indicated this was a total install base agreement (tiba) for the distributor to receive the speaker assembly spare part from philips.A good faith effort (gfe) response confirmed there was no sound and no speaker inoperative message at the time of the event.The gfe response informed philips, the unit is now working as intended.Based on the information available, the cause of the reported problem was confirmed to the speaker assembly.The reported problem was confirmed.If additional information is received the complaint file will be reopened.No further investigation or action is warranted at this time.

• Brand Name: SURESIGNS VS4
• Common Device Name: SURESIGNS VS4 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: 23664122
• Report Number: 1218950-2025-000704
• Device Sequence Number: 10402060
• Product Code: MHX
• UDI-Device Identifier: 00884838087095
• UDI-Public: (01)00884838087095
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K163649
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2025

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: 863283
• Device Catalogue Number: 863283
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 12/21/2025
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2019
• 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