MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VS4; GENERAL-PURPOSE MULTI-PARAMETER BEDSIDE MONITOR

Model Number	863283
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 reporting insitution phone #: (b)(4).E1 reporter phone #: (b)(6).A philips field service engineer (fse) went to the customer's site; however, the device was unable to be located.Therefore, the cause of the reported problem is unable to be determined.The product malfunction was unable to be confirmed because the customer was unable to locate the device.A review of the service history for this device confirms that 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
Philips received a complaint on a suresigns vs4 indicating that the blood pressure measurements taken are incorrect.The customer stated the device was not being used with patients.No adverse event was reported.

• Brand Name: SURESIGNS VS4
• Common Device Name: GENERAL-PURPOSE MULTI-PARAMETER BEDSIDE MONITOR
• 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: 24178857
• Report Number: 1218950-2026-100025
• Device Sequence Number: 13256837
• Product Code: MHX
• UDI-Device Identifier: 00884838087095
• UDI-Public: (01)00884838087095
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/26/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2019
• 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