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 Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
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 when starting corsium, the indicator light does not stay solid green and flashes.There is no stable connection.It was observed within the physician's toughbook, that the tempus pro monitor appears, but neither live transmission nor electrocardiogram (ecg) are visible.It is noted that the monitor has to be repeatedly turned off and on again.A request for additional information regarding the incident, including clarification of device that successfully measured ecg, has been sent and the response is not yet received.There was no report of actual harm reported with this complaint.
Additional Manufacturer Narrative
Product information and event description updated due to new information received.
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 starting corsium, the indicator light does not stay solid green and flashes.There is no stable connection.It was observed within the physician's toughbook, that the tempus pro monitor appears, but neither live transmission nor electrocardiogram (ecg) are visible.It is noted that the monitor has to be repeatedly turned off and on again by the user.Response to good faith effort indicated live transmission and ecg were visible on the tempus pro device and that the issue appeared to be with the connection to corsium.Further information provided indicated the user attempted troubleshooting upon returning to base with the device involved in the incident and also a second device.The second device was able to connect to corsium with no issues, however the device involved in the incident was unable to.There was no patient or user harm or impact as a result of the reported problem.
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 starting corsium, the indicator light does not stay solid green and flashes.There is no stable connection.It was observed within the physician's toughbook, that the tempus pro monitor appears, but neither live transmission nor electrocardiogram (ecg) are visible.It is noted that the monitor has to be repeatedly turned off and on again by the user.Response to good faith effort indicated live transmission and ecg were visible on the tempus pro device and that the issue appeared to be with the connection to corsium.Further information provided indicated the user attempted troubleshooting upon returning to base with the device involved in the incident and also a second device.The second device was able to connect to corsium with no issues, however the device involved in the incident was unable to.There was no patient or user harm or impact as a result of the reported problem.

• 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: 24027927
• Report Number: 3003832357-2026-100012
• Device Sequence Number: 12972014
• Product Code: MHX
• UDI-Device Identifier: 05060472441058
• UDI-Public: (01)05060472441058(11)220518
• 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): 02/06/2026

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: 01/07/2026
• Supplement Date Received by Manufacturer: 01/13/2026; 01/29/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/13/2026; 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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