MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION Q-STRESS; ELECTROCARDIOGRAPH

Model Number	N/A
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported a study was concluded with incorrect patient data.Baxter technical support provided the account troubleshooting steps to resolve the issue.The account confirmed demographics were corrected.Based on this information, no further action is required.Although there was no adverse event reported, if the reported event of incorrect patient demographics were to recur it could lead to serious injury or death, therefore baxter considers this event reportable.
Event or Problem Description
Baxter received a report stating that an exam had incorrect patient data in q-stress.The event occurred after patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: Q-STRESS
• Common Device Name: ELECTROCARDIOGRAPH
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): WELCH ALLYN PRODUCTS, MEXICO; emilio flores #2471-a2; caã¿â¿¿on del padre; tijuana, baja california 22203 ; MX 22203
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 25437196
• Report Number: 3006087789-2026-00005
• Device Sequence Number: 10095813
• Product Code: DPS
• UDI-Device Identifier: 00812345027563
• UDI-Public: (01)00812345027563
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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: N/A
• Device Catalogue Number: QS6-ATTD1
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 06/08/2026
• 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: Reuse
• 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