MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VS4

Model Number	863283
Medical Device Problem Code	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
Event or Problem Description
It was reported the speaker needed replacement.It is unknown if there was still sound present.Patient involvement is unknown.There was no report of patient or user harm.
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.E1: reporting institution phone#: (b)(6).E1: reporter phone#: (b)(6).
Additional Manufacturer Narrative
Multiple good faith efforts attempts conducted to gather more information about if the device still produced audio and if there was a speaker malfunction error inop displayed don the device were unsuccessful.The following functional tests were performed: the remote support engineer (rse) arranged a quote for a replacement speaker assembly was sent to the customer.Based on the information available and the testing conducted, the cause of the reported problem is a defective speaker.The reported problem was confirmed.The customer was provided with a replacement speaker assembly to resolve the issue.The device remains at customer site.It has been concluded that no further action is required at this time.

• Brand Name: SURESIGNS VS4
• Common Device Name: SURESIGNS VS4
• 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: 23727710
• Report Number: 1218950-2025-000720
• Device Sequence Number: 10258758
• 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
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: 863283
• Device Catalogue Number: 863283
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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