MAUDE Adverse Event Report: Remote Diagnostic Technologies Ltd. TEMPUS LS; SCHILLER AG

Model Number	00-3020
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	12/13/2025
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 ls manual defibrillator indicating during an emergency call on (b)(6) 2025, the crew connected the defibrillator to the patient with no heart rhythm shown and message onscreen "check electrodes".The crew member confirmed good placement on patient and connection, but no change with the tempus ls.A second set of pads were also attempted to obtain a 4-lead ecg (electrocardiogram), however the device had the same error "check electrodes".A third set of pads were used and monitor still displayed error "check electrodes".The crew reported the patient started in and maintained asystole (flatline) and pea (pulseless electrical activity) throughout the cardiac arrest.

• Brand Name: TEMPUS LS
• Common Device Name: SCHILLER AG
• 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; baar 6341 ; SZ 6341 ; +41()0417664242
• MDR Report Key: 23945662
• Report Number: 3003832357-2025-000947
• Device Sequence Number: 18100381
• Product Code: LDD
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/23/2026

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
• Device Lot Number: Y050924-05
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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