MAUDE Adverse Event Report: Philips Medical Systems SureSigns VS4; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Model Number	863283
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the suresigns vs4 nbp, spo2 indicating that the devices o2 monitor has a ghost read.It is unknown if the device was in use at time of event, and there was no adverse event reported.
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke with the biomed regarding the device's inaccurate spo2 parameter.The issue could not be replicated, and the cause is unknown.The rse advised the biomed that bench repair was not available because the device is eol/eos.The system does not meet the specification for the performed service and is not returned to use.The device does not meet the specification for the performed service and is not returned to use.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 ; +1(617)245-5900
• MDR Report Key: 50758643
• Report Number: 1218950-2026-100629
• Device Sequence Number: 9668187
• Product Code: MHX
• UDI-Device Identifier: 00884838087095
• UDI-Public: (01)00884838087095
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/14/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2019
• 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