MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS EXPRESSION MR WIRELESS SPO2 PATIENT MODULE (GEN 3) 1-5

Model Number	WIRELESS SPO2 3.0 MODULE (NETWORKS 1-5)
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on a wireless spo2 patient module (gen 3) 1-5 indicating that spo2 is giving incorrect readings and the customer wants to know if unit is not compatible with certain testing equipment; the readings seemed too high.The device was not in clinical use at the time the issue was discovered.No adverse event or harm was reported.
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer biomedical engineer (biomed).The customer was using a pronk simulator.The rse explained to the customer that this simulator is compatible.The rse advised the biomed to use their finger instead of the simulator for testing; readings from the biomed's finger were normal, indicating a possible issue with the pronk simulator spo2 accessory.Based on the information available and the testing conducted, the cause of the reported problem was a non-philips product.The philips device was confirmed to be operating per specifications and no failure was identified.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: EXPRESSION MR WIRELESS SPO2 PATIENT MODULE (GEN 3) 1-5
• Common Device Name: EXPRESSION MR WIRELESS SPO2 PATIENT MODULE (GEN 3) 1-5
• Manufacturer (Section D): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer (Section G): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer Contact: deborah currlin ; 12151 research parkway; orlando, FL 32826 ; 4072753220
• MDR Report Key: 22676354
• Report Number: 9610816-2025-000701
• Device Sequence Number: 8844486
• Product Code: MWI
• UDI-Device Identifier: 00884838055025
• UDI-Public: (01)00884838055025
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152330
• 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): 07/31/2025

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: WIRELESS SPO2 3.0 MODULE (NETWORKS 1-5)
• Device Catalogue Number: 989803192771
• 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: 07/25/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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