MAUDE Adverse Event Report: SCHILLER AG CARDIOPULMONARY RESUSCITATION; CARDIOPULMONARY RESUSCITATION (CPR) AID

Model Number	01-3023
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This report is based on information provided by the remote service engineer rse and has been investigated by the philips complaint handling team.Philips received a complaint about the tempus ls manual, stating that the cpr sensor (cardiopulmonary resuscitation) accessories are not providing accurate feedback.

• Brand Name: CARDIOPULMONARY RESUSCITATION
• Common Device Name: CARDIOPULMONARY RESUSCITATION (CPR) AID
• 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: 23474741
• Report Number: 3003832357-2025-000832
• Device Sequence Number: 21472394
• Product Code: LIX
• UDI-Device Identifier: 07613365002737
• UDI-Public: (01)07613365002737
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 11/05/2025

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: 01-3023
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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