MAUDE Adverse Event Report: SCHILLER AG SCHILLER AG; ARGUS PB-1000

Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Describe the event or problem: merge hemodynamic system not working as designed, unable to work in cath lab room #4.What was the original intended procedure?: extraction of dual-chamber pacemaker, left heart catheterization and right heart catheterization.What problem did the user have: device failed (e.G.Broke, couldn't get it to work or stopped working).Therapies being used on the patient at the time of the event that may have caused or contributed to the event: not known.Additional information for patient #1: other information about the patient that may have influenced the outcome of the event: n/a.Preexisting characteristics that may have contributed to the event: hepatic/renal dysfunction; other; coronary heart disease.Other characteristics or medical conditions: aortic stenosis, atrial fibrillation, severe mitral valve regurgitation, ckd.

• Brand Name: SCHILLER AG
• Common Device Name: ARGUS PB-1000
• Manufacturer (Section D): SCHILLER AG; altgasse 68; baar, zg 6341 ; SZ 6341
• Manufacturer (Section G): MERGE HEALTHCARE
• Manufacturer Contact: stefan bigler ; altgasse 68; baar, zg 6341 ; SZ 6341
• MDR Report Key: 24566537
• Report Number: 8030978-2026-91337
• Device Sequence Number: 8366668
• Product Code: MHX
• UDI-Device Identifier: 07613365000085
• UDI-Public: 07613365000085
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K012226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/11/2026
• Date Device Manufactured: 08/13/2021
• 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
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White