MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION Welch Allyn VS100 Spot Vision Screener; Refractometer, ophthalmic

Model Number	901029
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that vs100 spot vision screener had its power cord damaged with exposed copper wires.The process step during which this occurred was unknown.There was no report of patient injury or medical intervention associated with these events.
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.

• Brand Name: Welch Allyn VS100 Spot Vision Screener
• Common Device Name: Refractometer, ophthalmic
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): WELCH ALLYN PRODUCTS, SKANEATELES; 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: 50184461
• Report Number: 1316463-2026-00329
• Device Sequence Number: 18718303
• Product Code: HKO
• UDI-Device Identifier: 00732094212235
• UDI-Public: (01)00732094212235
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/07/2026

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: 901029
• Device Catalogue Number: VS100S-B
• 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: 07/13/2026
• Initial Report FDA Received Date: 08/07/2026
• 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