MAUDE Adverse Event Report: Schiller AG Tempus LS-Manual; Low Energy Defibrillator

Catalog Number	989706001681
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This report is based on information provided by a philips remote service engineer, a bench engineer and a technical engineer and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus ls manual indicating that the not capturing all 3 leads.No patient involvement was reported; therefore, there were no health consequences or impact.

• Brand Name: Tempus LS-Manual
• 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: 50766698
• Report Number: 3003832357-2026-100526
• Device Sequence Number: 18529432
• Product Code: LDD
• UDI-Device Identifier: 07613365002737
• Combination Product (Y/N): N
• 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: User Facility
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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
• Device Catalogue Number: 989706001681
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown