MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SOFTWARE HSCRIBE; ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM

Model Number	901143
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Malfunction

• Brand Name: SOFTWARE HSCRIBE
• Common Device Name: ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM
• 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 ; +1(224)270-5355
• MDR Report Key: 50090433
• Report Number: 1316463-2026-00325
• Device Sequence Number: 9913249
• Product Code: MLO
• UDI-Device Identifier: 00732094281330
• UDI-Public: (01)00732094281330
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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 Model Number: 901143
• Device Catalogue Number: MM-HSCRIBE-DICOM
• 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: 07/06/2026
• Initial Report FDA Received Date: 07/30/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown