MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION HScribe; Electrocardiograph, Ambulatory, With Analysis Algorithm

Catalog Number	HSERV-6AA-XXXXB
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction

• Brand Name: HScribe
• Common Device Name: Electrocardiograph, Ambulatory, With Analysis Algorithm
• 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: 50906106
• Report Number: 3006087789-2026-00026
• Device Sequence Number: 14974135
• Product Code: MLO
• UDI-Device Identifier: 00817655020228
• UDI-Public: (01)00817655020228
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: HSERV-6AA-XXXXB
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/25/2026
• 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
• Patient Sex: Unknown