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 Codes	Computer Operating System Problem (2898); Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
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 during a medical intervention; while recording and attempting to send the 12-lead electrocardiogram (ecg) to jihlava cardiology center, the device made a sound, began a startup test and then froze.The device would not respond.A request for additional information regarding the incident has been sent, including a request for confirmation of successful subsequent transmission of 12-lead ecg waveform, and the response is not yet received.There was no report of actual harm reported with this complaint.
Additional Manufacturer Narrative
Event description updated due to new information obtained through good faith effort.
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; while recording and attempting to send the 12-lead electrocardiogram (ecg) to jihlava cardiology center, the device made a sound, began a startup test and then froze.The device would not respond.Information obtained through good faith effort indicated the 12-lead ecg was successfully sent during the incident.No harm or impact occurred to the patient during the incident.
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 during a medical intervention; while recording and attempting to send the 12-lead electrocardiogram (ecg) to (b)(6) center, the device made a sound, began a startup test and then froze.The device would not respond.Information obtained through good faith effort indicated the 12-lead ecg was successfully sent during the incident.No harm or impact occurred to the patient during the incident.

• 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: 24718174
• Report Number: 3003832357-2026-100194
• Device Sequence Number: 5726642
• Product Code: MHX
• 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): 05/20/2026

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: 00-1024-R
• Device Catalogue Number: 989706000051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 04/30/2026; 05/20/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/30/2026; 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2020
• 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