MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VS4; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

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	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the suresigns vs4 indicating that the speaker defective.Good faith efforts were made to see if the speaker produced sound at time of event.It is unknown if the device was in use on patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
The following functional tests and communications were performed: multiple good faith efforts attempts have been conducted to gather more information but have been unsuccessful.Based on the information available and the testing conducted, the cause of the reported problem is unknown.The reported problem was not confirmed.It was noted that a speaker was shipped to the customer, however multiple good faith efforts attempts have been conducted to gather more information but have been unsuccessful.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: SURESIGNS VS4
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• 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: 23574781
• Report Number: 1218950-2025-000675
• Device Sequence Number: 9885674
• Product Code: MHX
• UDI-Device Identifier: 00884838087095
• UDI-Public: (01)00884838087095
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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
• Device Model Number: 863283
• Device Catalogue Number: 863283
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/17/2025
• Date Device Manufactured: 06/18/2018
• 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