MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VS2+

Model Number	863278
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
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.An email was sent to the customer to obtain more information.The customer responded that the audio test message was accepted; however, it came back after disconnecting and reconnecting the battery.The message disappears after each audio test.The customer returned the device to service and agreed to call back if it occurs again.E1: reporter institution phone number: (b)(6).E1: reporter phone number:.
Event or Problem Description
The customer reported during tests performed the suresigns vs2+ indicating error message speaker fault audio problem.The device was not in use on a patient at the time of the event.No adverse event to the patient or user was reported.It is unknown if there was sound produced by the device.
Additional Manufacturer Narrative
Good faith effort (gfe) attempts were conducted to clarify if the speaker produced sound, but no further information could be received and it remains unknown.The customer responded that the audio test message was accepted; however, it came back after disconnecting and reconnecting the battery.The message disappears after each audio test.Based on the information available and the testing conducted, we were unable to confirm the cause of the reported problem.The device was put back in service at the customer site.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: SURESIGNS VS2+
• Common Device Name: SURESIGNS VS2+
• 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: 22562970
• Report Number: 1218950-2025-000411
• Device Sequence Number: 14458416
• Product Code: DSK
• UDI-Device Identifier: 00884838028395
• UDI-Public: (01)00884838028395
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111114
• 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,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2018
• 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