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

Model Number	863283
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis was performed by a philips remote service engineer (rse) which included interviewing the customer and troubleshooting the unit.The unit failed the nibp accuracy test.The rse advised the customer the unit was end of life.As a result, the unit's parts may no longer be manufactured or shipped by philips.The rse informed the customer of the nibp pump assembly that would require replacement and provided the part id, which went obsolete: 2025-12-31.The rse offered to send end of life documentation; however, the customer declined.No further assistance was needed concluding remote technical support.Based on the available analysis, it was determined that the device experienced a malfunction.However, the most probable root cause of the reported issue could not be conclusively determined at this time.It is suspected that the issue may be related to the device being out of calibration or a potential failure of the nbp pump.A review of the service history for this device confirms the problem has not been reported again for this device.If additional information is received, the complaint file will be reopened for further investigation.
Event or Problem Description
The customer reported that the unit is failing nibp accuracy test during a preventive maintenance.The device was not in use on a patient at the time of event, there was no adverse event reported.

• 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: 24867674
• Report Number: 1218950-2026-100223
• Device Sequence Number: 18373034
• Product Code: MHX
• UDI-Device Identifier: 00884838087095
• UDI-Public: (01)00884838087095
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/14/2026

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: 03/19/2026
• Initial Report FDA Received Date: 04/13/2026
• Date Device Manufactured: 10/04/2019
• 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