MAUDE Adverse Event Report: SCHILLER AG LOW ENERGY DEFIBRILLATOR

Model Number	00-3020
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This report is based on information provided by a philips remote service engineer and a bench engineer and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus ls indicating that the measure joules value is out of range during preventive maintenance.The device was not in use, therefore no health consequences or impact.

• Brand Name: LOW ENERGY DEFIBRILLATOR
• 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: 24916050
• Report Number: 3003832357-2026-100226
• Device Sequence Number: 21282162
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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 Model Number: 00-3020
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 06/03/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown