MAUDE Adverse Event Report: Remote Diagnostic Technologies Ltd. TEMPUS PRO; MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	00-1024-R
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
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 at the beginning of the users shift, when turning on the monitor, the main screen froze and wouldn't respond to clicks on new patient, the screen or turning off with the green power button.The monitor subsequently restarted itself but took longer than usual to load to the main screen.Following this restart, the device was functional.When powering off, a small black box with an error message appeared, however the user does not recall what the error message stated and an image of the error was not taken.During the incident, the device beeped three times, but the tone of the beeping was observed to be different than expected.The user removed the device from service.A request for additional information regarding the incident has been sent and the response is not yet received.As the incident occurred during shift change, there was no patient involvement at the time of the incident, no harm or impact occurred.
Event or Problem Description
This report is based on information provided by philips remote service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating that at the beginning of the users shift, when turning on the monitor, the main screen froze and wouldn't respond to clicks on new patient, the screen or turning off with the green power button.The monitor subsequently restarted itself but took longer than usual to load to the main screen.Following this restart, the device was functional.When powering off, a small black box with an error message appeared, however the user does not recall what the error message stated and an image of the error was not taken.During the incident, the device beeped three times, but the tone of the beeping was observed to be different than expected.The user removed the device from service.As the incident occurred during shift change, there was no patient involvement at the time of the incident, no harm or impact occurred.
Additional Manufacturer Narrative
Health impact code grid updated.

• 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: 25654366
• Report Number: 3003832357-2026-100379
• Device Sequence Number: 5865308
• Product Code: MHX
• UDI-Device Identifier: 05060472441027
• UDI-Public: (01)05060472441027(11)200408
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 08/26/2026

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: Other
• Device Model Number: 00-1024-R
• Device Catalogue Number: 989706000051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Supplement Date Received by Manufacturer: 07/16/2026; 08/26/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 07/21/2026; 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2020
• 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