MAUDE Adverse Event Report: SCHILLER AG BP-200 PLUS

Model Number	3.930300
Medical Device Problem Codes	Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device functions normally during resting blood pressure measurements.However, during stress testing, the device fails to display blood pressure values after stage 2, and occasionally during stage 2 as well.The user also experienced error codes 180, 181, and 182, along with occasional abnormal blood pressure readings during stress tests.
Additional Manufacturer Narrative
The error was displayed consistently.Based on the problem description and according to the risk estimation and acceptance criteria, an unusable device is classified as severity "s1" and could therefore results or may result in reversible impairment or injury that is transient and that does not require medical or surgical intervention.
Event or Problem Description
The customer reported that the device functions normally during resting blood pressure measurements.However, during stress testing, the device fails to display blood pressure values after stage 2, and occasionally during stage 2 as well.The user also experienced error codes 180, 181, and 182, along with occasional abnormal blood pressure readings during stress tests.

• 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: 21661633
• Report Number: 8030978-2025-77720
• Device Sequence Number: 12923489
• Product Code: DQA
• UDI-Device Identifier: 07613365000122
• UDI-Public: 07613365000122
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K063814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: 505
• 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: Health Professional
• Device Model Number: 3.930300
• Device Catalogue Number: 0.310000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2019
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown