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 Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the suresigns vs4 nbp, spo2 indicating that the unit audio failed and speaker malfunction inop on screen.The device was not in clinical use at time of event and no patient involvement.
Additional Manufacturer Narrative
The following functional tests were performed: the remote service engineer (rse) spoke to the customer and confirmed the speaker malfunction error message and no audio.The rse advised the customer to run an audio test.When walking him through the audio test, three tones sounded, autioand the error went away.All audio was present and speakers were functioning as intended.The cause audio failed and message on screen is unknown.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.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 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: 23383750
• Report Number: 1218950-2025-000627
• Device Sequence Number: 15641587
• Product Code: MHX
• UDI-Device Identifier: 00884838087095
• UDI-Public: (01)00884838087095
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/24/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2018
• 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