MAUDE Adverse Event Report: Remote Diagnostic Technologies Ltd. TEMPUS LS; LOW ENERGY DEFIBRILLATOR

Model Number	00-3020
Medical Device Problem Code	Failure to Discharge (1169)
Health Effect - Clinical Codes	Unspecified Heart Problem (4454); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This report is based on information provided by remote service engineer rse and is currently under investigation by the philips complaint handling team.Philips received a complaint on the tempus pro indicating while on a call, the crew report the monitor was powered on and charged appropriately for defibrillation.On multiple occasions, after charging to the selected energy level, activation of the shock button did not deliver a shock.In at least one instance, the charge was automatically cancelled when attempting to deliver the shock.At other times during the same resuscitation, the device functioned normally and successfully delivered defibrillation.Additionally, there were episodes of noticeable delay between pressing the shock button and energy delivery.The crew also report this malfunction was intermittent and inconsistent throughout the event.There was no reported impact to the patient at this time.

• Brand Name: TEMPUS LS
• Common Device Name: LOW ENERGY DEFIBRILLATOR
• 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 ; altgasse 68; aerospace boulevard; baar 6341 ; SZ 6341 ; +41()0417664242
• MDR Report Key: 24574327
• Report Number: 3003832357-2026-100151
• Device Sequence Number: 10474682
• Product Code: LDD
• UDI-Device Identifier: 07613365002737
• UDI-Public: (01)07613365002737
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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: 00-3020
• Device Catalogue Number: 989706001681
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 09/28/2026
• 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