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	Unable to Obtain Readings (1516)
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 attempting to record 12-lead electrocardiogram (ecg), no ecg waveform appeared on the monitor for any lead.The user checked and reapplied the ecg leads several times, however the issue persisted.Further information indicates the ecg waveform was successfully recorded using "tempus pro crew of the ambulance" but it is unclear if this is a different tempus pro device or the same device.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.
Event or Problem Description
This report is based on information provided by philips remote service personnel and is currently being investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating that during a medical intervention when attempting to record 12-lead electrocardiogram (ecg), no ecg waveform appeared on the monitor for any lead.The user checked and reapplied the ecg leads several times; however, the issue persisted.Response to good faith effort indicated the ecg waveform was successfully recorded using a second tempus pro device that was used from the doctor's car which was also onsite with the same patient.No patient or user harm was confirmed as a result of the incident.
Additional Manufacturer Narrative
Product information and description updated due to new information received.
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 when attempting to record 12-lead electrocardiogram (ecg), no ecg waveform appeared on the monitor for any lead.The user checked and reapplied the ecg leads several times, however the issue persisted.Response to good faith effort indicated the ecg waveform was successfully recorded using a second tempus pro device that was used from the doctor's car which was also onsite with the same patient.No patient or user harm was confirmed as a result of the incident.
Additional Manufacturer Narrative
Information obtained through good faith effort indicated event date to be 02jan2026.
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 when attempting to record 12-lead electrocardiogram (ecg), no ecg waveform appeared on the monitor for any lead.The user checked and reapplied the ecg leads several times, however the issue persisted.Response to good faith effort indicated the ecg waveform was successfully recorded using a second tempus pro device that was used from the doctor's car which was also onsite with the same patient.No patient or user harm was confirmed as a result of the incident.
Additional Manufacturer Narrative
Component code updated.
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 when attempting to record 12-lead electrocardiogram (ecg), no ecg waveform appeared on the monitor for any lead.The user checked and reapplied the ecg leads several times, however the issue persisted.Response to good faith effort indicated the ecg waveform was successfully recorded using a second tempus pro device that was used from the doctor's car which was also onsite with the same patient.No patient or user harm was confirmed as a result of 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 when attempting to record 12-lead electrocardiogram (ecg), no ecg waveform appeared on the monitor for any lead.The user checked and reapplied the ecg leads several times, however the issue persisted.Response to good faith effort indicated the ecg waveform was successfully recorded using a second tempus pro device that was used from the doctor's car which was also onsite with the same patient.No patient or user harm was confirmed as a result of 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: 24010352
• Report Number: 3003832357-2026-100008
• Device Sequence Number: 21144822
• Product Code: MHX
• UDI-Device Identifier: 05060472441058
• UDI-Public: (01)05060472441058
• 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,Followup
• Report Date (Section B): 04/09/2026

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: 01/06/2026
• Supplement Date Received by Manufacturer: 01/13/2026; 03/10/2026; 03/10/2026; 04/02/2026; 04/02/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 01/15/2026; 03/17/2026; 03/31/2026; 04/07/2026; 04/09/2026
• 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