MAUDE Adverse Event Report: SCHILLER AG TEMPUS LS; LOW ENERGY DEFIBRILLATOR

Model Number	00-3020
Medical Device Problem Code	Inappropriate Waveform (2536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This report is based on information provided by a remote service engineer and is currently under investigation by the philips complaint handling team.Philips received a complaint on the tempus ls manual defibrillator indicating when pacing, while using a simulator as the patient, the red pacer spikes are sporadic in their appearance and then eventually disappear.The monitor will actually pace as you can see when it gets capture by the changing of the width of the qrs, however there is no pacer spike prior to the qrs as it should be.The customer is an ems training facility and were using it with training of paramedic students with a simulator as the patient, there is no patient involvement.The unit did not act as if anything was wrong.After a long shut down it was turned back on and returned to normal presentation of pacer spikes then loses them.

• Brand Name: TEMPUS LS
• Common Device Name: LOW ENERGY DEFIBRILLATOR
• Manufacturer (Section D): SCHILLER AG; altgasse 68; baar 6341 ; SZ 6341
• Manufacturer (Section G): Schiller AG; altgasse 68; baar 6341 ; SZ 6341
• Manufacturer Contact: sharunyan thavarajan ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 24456829
• Report Number: 3003832357-2026-100123
• Device Sequence Number: 9403495
• Product Code: LDD
• UDI-Device Identifier: 07613365002737
• UDI-Public: (01)07613365002737
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 08/26/2026

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 06/22/2026; 08/26/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 07/07/2026; 08/26/2026
• 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