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	Erratic or Intermittent Display (1182); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
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 when the user attempted to set touchscreen for activating printing or sending electrocardiogram (ecg), the touchscreen quickly reverted to the default display.The user indicated this occurred repeatedly.No harm occurred to the patient.A request for additional information regarding the incident has been sent and the response is not yet received.
Additional Manufacturer Narrative
Device problem code updated due to additional information regarding incident provided within good faith effort response.
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 when the user attempted to set touchscreen for activating printing or sending electrocardiogram (ecg), the touchscreen quickly reverted to the default display.The user indicated this occurred repeatedly.No harm occurred to the patient.Response to good faith effort indicated the ecg was successfully measured during the incident.Ecg recording was then successfully sent to clinical via email.Log files were provided for further analysis.Final investigation results are pending completed investigation.
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 when the user attempted to set touchscreen for activating printing or sending electrocardiogram (ecg), the touchscreen quickly reverted to the default display.The user indicated this occurred repeatedly.No harm occurred to the patient.Response to good faith effort indicated the ecg was successfully measured during the incident.Ecg recording was then successfully sent to clinical via email.
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 when the user attempted to set touchscreen for activating printing or sending electrocardiogram (ecg), the touchscreen quickly reverted to the default display.The user indicated this occurred repeatedly.No harm occurred to the patient.Response to good faith effort indicated the ecg was successfully measured during the incident.Ecg recording was then successfully sent to clinical via email.
Additional Manufacturer Narrative
Method 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: 23795271
• Report Number: 3003832357-2025-000899
• Device Sequence Number: 18759480
• 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,Followup
• Report Date (Section B): 02/16/2026

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: 12/10/2025
• Supplement Date Received by Manufacturer: 12/22/2025; 01/19/2026; 02/16/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 12/22/2025; 01/19/2026; 02/16/2026
• 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