MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VS4; SURESIGNS VS4 NBP, SPO2

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	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was an audio failure.It was confirmed there was no speaker malfunction inoperative error message present.It is unknown if the device was in use at time of event, and there was no adverse event reported.
Additional Manufacturer Narrative
The following functional tests were performed: a philips field service engineer (fse) arrived onsite to further evaluate the unit.The fse tested the unit through service mode hearing, and it gave 3 tones, the customer's allegation could not be replicated.Further evaluation of the unit did not occur since the unit has been deemed end of life (eol) and part replacement is obsolete.Based on the information available and the testing conducted, the cause could not be replicated.The reported problem was not confirmed.The investigation concludes that no further action is required at this time.No further investigation or action is warranted at this time.

• Brand Name: SURESIGNS VS4
• Common Device Name: SURESIGNS VS4 NBP, SPO2
• 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: 22470762
• Report Number: 1218950-2025-000383
• Device Sequence Number: 11830361
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: 06/11/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2019
• 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