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	Incorrect Measurement (1383)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Hemodynamic instability (4868)
Date of Event	03/13/2026
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 after the user connected etco2 (capnography), the capnograph shows different values (10, 0, 70).User attempted to troubleshoot, but problem persisted.After connecting to the transport monitor, etco2 then showed stable values.A request for additional information regarding the incident has been sent and the response is not yet received.There was no report of actual harm reported with this complaint.
Additional Manufacturer Narrative
Serial number updated.Event description updated.
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 monitoring patient's unstable blood circulation; after the user connected etco2 (capnography), the capnograph showed different values (10, 0, 70).User attempted to troubleshoot by connecting a second etco2 sensor, but issue persisted.Information obtained within good faith effort indicated sensors were properly connected to the monitor and airway circuit and were operating under specified temperature and humidity range.Both sensors were indicated to be new.No alarms or messages occurred.Sensors were stored in original bag(s) prior to use.A laryngeal mask airway (lma) was used.After connecting to the rendezvous monitor, etco2 then showed stable values.There was no report of actual harm reported with this complaint.
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 monitoring patient's unstable blood circulation; after the user connected etco2 (capnography), the capnograph showed different values (10, 0, 70).User attempted to troubleshoot by connecting a second etco2 sensor, but issue persisted.Information obtained within good faith effort indicated sensors were properly connected to the monitor and airway circuit and were operating under specified temperature and humidity range.Both sensors were indicated to be new.No alarms or messages occurred.Sensors were stored in original bag(s) prior to use.A laryngeal mask airway (lma) was used.After connecting to the rendezvous monitor, etco2 then showed stable values.There was no report of actual harm reported with this complaint.

• 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: 24623701
• Report Number: 3003832357-2026-100162
• Device Sequence Number: 8853050
• Product Code: MHX
• UDI-Device Identifier: 05060472441027
• UDI-Public: (01)05060472441027(11)200325
• 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): 05/05/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 03/13/2026; 04/27/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 03/25/2026; 05/05/2026
• 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