MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION WELCH ALLYN DIAGNOSTIC CARDIOLOGY SUITE; SPIROMETER, DIAGNOSTIC

Model Number	901128
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Event or Problem Description
A customer contacted technical service to report that the diagnostic cardiology suite had incorrect patient information pulled in when taking exam through veradigm/allscripts.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: WELCH ALLYN DIAGNOSTIC CARDIOLOGY SUITE
• Common Device Name: SPIROMETER, DIAGNOSTIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): WELCH ALLYN CARDIO PRODUCTS, MILWAUKEE; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 25250016
• Report Number: 1316463-2026-00303
• Device Sequence Number: 10547722
• Product Code: BZG
• UDI-Device Identifier: 00732094325386
• UDI-Public: (01)00732094325386
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 901128
• Device Catalogue Number: DCSS-CXX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown