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	05/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on a suresigns vs4 nbp, spo2 device indicating that during routine testing, the device failed the alarm test.There was a speaker malfunction.The device was not in use on patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
Analysis was performed by onsite service personnel which included functional testing and troubleshooting.The results of the analysis confirmed a speaker malfunction error was displayed and there was no audible sound from the device.Another speaker from a working device was tried and the speaker malfunction error persisted.A review of the service history for this device shows the problem had not been reported again for this device.Based on the results of the analysis, it was determined that the product has malfunctioned and the most likely cause of the reported problem was a faulty mainboard.The issue was resolved by replacing the speaker and the mainboard.Based on the information available and results of additional analysis, no further action is necessary at this time.If additional information is received, the complaint file will be reopened for further investigation.

• 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: 25597901
• Report Number: 1218950-2026-100438
• Device Sequence Number: 9922957
• Product Code: MHX
• UDI-Device Identifier: 00884838087095
• UDI-Public: (01)00884838087095
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: 863283
• Device Catalogue Number: 863283
• 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: 05/27/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2019
• 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