MAUDE Adverse Event Report: REMOTE DIAGNOSTIC TECHNOLOGIES LTD. TEMPUS PRO; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	00-1004-R
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This report is based on information provided by philips regulatory affairs team and will be investigated by the philips complaint handling team.Philips received a complaint via a user report on the tempus pro indicating that using the side charging port leads to charging socket failure.A request for additional information regarding the incident and potential patient involvement has been sent and the response is not yet received.There was no report of actual harm associated within the incident description of the user report, however, an annex f code of a delay in diagnosis was reported.Additional information has been requested to confirm the discrepancy and provide additional event details.
Additional Manufacturer Narrative
Imdrf codes / fda - codes within the user report as follows: annex a = a2203 / c79146.Annex e = e2403 / c106101.Annex f = f04 / c171962.There was no report of actual harm associated within the incident description of the user report, however, an annex f code of a delay in diagnosis was reported.Additional information has been requested to confirm the discrepancy and provide additional event details.

• 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: 23000085
• Report Number: 3003832357-2025-000663
• Device Sequence Number: 8997345
• Product Code: MHX
• UDI-Device Identifier: 05060472442901
• UDI-Public: (01)05060472442901
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 12/15/2025

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: 00-1004-R
• Device Catalogue Number: 867420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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