MAUDE Adverse Event Report: SCHILLER AG BP-200 PLUS

Catalog Number	3.930300
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a stress test the device showed very high blood pressure values.

• Brand Name: BP-200 PLUS
• Common Device Name: BP-200 PLUS
• 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: 20565839
• Report Number: 3002808182-2024-70169
• Device Sequence Number: 15422002
• Product Code: DQA
• UDI-Device Identifier: 07613365000122
• UDI-Public: 07613365000122
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K063814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 10/30/2024

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: Health Professional
• Device Catalogue Number: 3.930300
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown