MAUDE Adverse Event Report: SCHILLER AG CARDIOVIT FT-1

Model Number	3.900863
Medical Device Problem Codes	Computer Software Problem (1112); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a warning was missing when two leads were reversed.Unknown if patient involved or harmed.
Event or Problem Description
The customer reported that a warning was missing when two leads were reversed.No patient involved.

• Brand Name: CARDIOVIT FT-1
• Common Device Name: CARDIOVIT FT-1
• Manufacturer (Section D): SCHILLER AG; altgasse 68; baar, zg 6341 ; SZ 6341
• Manufacturer (Section G): SCHILLER AG; altgasse 68; baar, zg 6341 ; SZ 6341
• Manufacturer Contact: stefan bigler ; altgasse 68; baar, zg 6341 ; SZ 6341
• MDR Report Key: 21547465
• Report Number: 8030978-2025-77111
• Device Sequence Number: 20797578
• Product Code: DPS
• UDI-Device Identifier: 07613365002867
• UDI-Public: 07613365002867
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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
• Operator of Device: Other
• Device Model Number: 3.900863
• Device Catalogue Number: 0A.106000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown