MAUDE Adverse Event Report: REMOTE DIAGNOSTIC TECHNOLOGIES LTD. TEMPUS PRO; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	00-1026-R
Medical Device Problem Codes	Fitting Problem (2183); Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This report is based on information provided by philips remote service personnel and will be investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating that during a medical intervention when defibrillator electrodes were attached to the defibrillator, the defibrillator did not pair with the monitor.A request for additional information regarding the incident has been sent and the response is not yet received.There was no report of actual harm reported with this complaint.
Event or Problem Description
This report is based on information provided by philips remote service personnel and will be investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating that during a medical intervention when defibrillator electrodes were attached to the defibrillator, the defibrillator did not pair with the monitor and printing of the electrocardiogram (ecg) was not possible.Information obtained via good faith effort indicated the patient was deceased prior to the deployment of the device.As the event occurred, post-mortem, the reported issue did not cause or contribute to patient harm or death.Analysis of the incident log files are pending at this time.
Additional Manufacturer Narrative
Product information and patient information updated due to new information obtained.

• Brand Name: TEMPUS PRO
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): REMOTE DIAGNOSTIC TECHNOLOGIES LTD.; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 6XW; UK GU14 6XW
• Manufacturer (Section G): REMOTE DIAGNOSTIC TECHNOLOGIES LTD.; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 6XW; UK GU14 6XW
• Manufacturer Contact: sharunyan thavarajan ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 23934945
• Report Number: 3003832357-2025-000946
• Device Sequence Number: 5739791
• Product Code: MHX
• UDI-Device Identifier: 05060472441058
• UDI-Public: (01)05060472441058(11)220520
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K201746
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2026

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: 00-1026-R
• Device Catalogue Number: 989706000101
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 02/11/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 01/16/2026; 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2022
• 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