MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION Q-Stress; Electrocardiograph

Catalog Number	QS6-ATTDX
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that an exam was done earlier under the wrong patient information.This occurred after patient use.There was no patient injury or death reported with this event.
Additional Manufacturer Narrative
Customer reported an exam was listed under the wrong patient.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 exams listed under the wrong patient were to recur it could lead to serious injury or death, therefore baxter considers this event reportable.

• 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 NA 22203 ; MX 22203
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; +1(224)270-5355
• MDR Report Key: 50812898
• Report Number: 3006087789-2026-00025
• Device Sequence Number: 10158075
• Product Code: DPS
• UDI-Device Identifier: 00812345027570
• UDI-Public: (01)00812345027570
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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
• Device Catalogue Number: QS6-ATTDX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown