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

Model Number	863283
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on a suresigns vs4 nbp, spo2 indicating that the device was displaying elevated vital sign readings.Upon initial follow-up, facility staff clarified that the concern involved high blood pressure (nbp) readings observed overnight.Staff indicated they had attempted to use a different machine; however, they were unsure whether different hoses or cuffs had been used during troubleshooting.The device was reported to be in clinical use.No adverse event to the patient or user was reported.
Additional Manufacturer Narrative
Biomed contacted the facility to gather additional details and inquired whether alternate cables and cuffs had been tested.Staff confirmed that these components had not been changed and agreed to perform further troubleshooting and provide an update.The customer later reported that the issue persisted.A biomed technician subsequently visited the site to evaluate the device and verified that the non-invasive blood pressure (nbp) readings were consistently elevated.During calibration testing, the unit failed to exceed the minimum pressure threshold of 199 mmhg, indicating a malfunction.Based on the evaluation, it was determined that the device had experienced a product malfunction.The most likely root cause of the issue was identified as a faulty nbp pump.To resolve the issue, a replacement nbp pump was ordered.Based on the information available and results of additional analysis, no further action is necessary at this time.

• 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: 24689433
• Report Number: 1218950-2026-100175
• Device Sequence Number: 15953702
• Product Code: MHX
• UDI-Device Identifier: 00884838087095
• UDI-Public: (01)00884838087095
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2019
• 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