MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CAREEVENT; SYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS

Model Number	CAREEVENT
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on a careevent indicating a connection error in all telemetry, connection error also comes out in the control panel.It seems that everything is down.The device was in use on a patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
E1; reporter institution phone number: (b)(6).E1: reporter phone number: (b)(6).Analysis was performed and it was stated that services are restarted at the careevent.The customer was to instruct the user to checked to make sure everything is working correctly.Based on the information available through remote trouble shooting, it was determined that the product has malfunctioned; however, the cause of the issue is unknown.The issue was resolved by restarting the device.A review of the service history for this device shows the problem has not been reported again for this device.

• Brand Name: CAREEVENT
• Common Device Name: SYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS
• 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: 25136162
• Report Number: 1218950-2026-100307
• Device Sequence Number: 9516087
• Product Code: MSX
• UDI-Device Identifier: 00884838099128
• UDI-Public: (01)00884838099128(10)C.03.02
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K161164
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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: CAREEVENT
• Device Catalogue Number: 866435
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2020
• 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