MAUDE Adverse Event Report: Remote Diagnostic Technologies Ltd. Tempus Pro, Printer; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Model Number	00-1024-R
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This report is based on information provided by a philips remote service engineer (rse) and will be investigated by the philips complaint handling team.Philips received a complaint concerning a tempus pro device.It was reported that, upon startup, a screen appeared prompting the user to select ¿abort turn off,¿ after which the device automatically powered off.As a result, a 12-lead ecg could not be obtained for a patient experiencing chest pain until a double-crewed ambulance (dca) arrived with a lifepak 15 (lp15) monitor/defibrillator.The tempus pro monitor was subsequently removed from service.The patient was transferred to another device, and alternative monitoring was implemented.No injury or adverse outcome was reported in association with this event.

• Brand Name: Tempus Pro, Printer
• 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: 50689012
• Report Number: 3003832357-2026-100515
• Device Sequence Number: 5155592
• Product Code: MHX
• UDI-Device Identifier: 05060472442925
• UDI-Public: (01)05060472442925
• Combination Product (Y/N): N
• Initial Reporter State: GB
• 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
• Report Date (Section B): 09/09/2026

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: 00-1024-R
• Device Catalogue Number: 867422
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/09/2026
• 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