MAUDE Adverse Event Report: Remote Diagnostic Technologies Ltd. Tempus Pro, BT Headset Dock; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Model Number	00-1007-R
Medical Device Problem Code	No Tactile Prompts/Feedback (4024)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This report is based on information provided by remote service engineer rse and is currently under investigation by the philips complaint handling team.Philips received a complaint on the tempus pro indicating the touch was inaccurate.The bench engineer confirmed the touch issues caused by physical damage to the screen protector.Once the bench engineer removed the screen protector, there are no longer any touch issues.However, there is an observed dent in the display, so replacement of the display is recommended.There was no impact to the patient and no harm was reported.

• Brand Name: Tempus Pro, BT Headset Dock
• 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: 50718797
• Report Number: 3003832357-2026-100516
• Device Sequence Number: 15953919
• Product Code: MHX
• UDI-Device Identifier: 05060472442918
• UDI-Public: (01)05060472442918
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 00-1007-R
• Device Catalogue Number: 867421
• 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: 08/17/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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