MAUDE Adverse Event Report: WELCH ALLYN INC EXAM LT IV LED W/TABLE/WALL MOUNT DOM; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number	48810
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The welch allyn gs exam light iv is designed to meet the various needs of the physician¿s office, hospital environment and specialist¿s office.It is not intended for rendering diagnosis or surgery.The gs exam light iv light is mounted on a mobile stand or table/wall mount.A replacement of the device was sent to the customer.Based on this information, no further actions are required at this time.Although there was no reported injury with this event, if the report of exposed wiring were to recur, it could potentially cause serious injury or death.Therefore, baxter is reporting this event.
Event or Problem Description
Customer reported exposed wiring and device not turning on.This report was filed in our complaint handling system as complaint #: (b)(4).

• Brand Name: EXAM LT IV LED W/TABLE/WALL MOUNT DOM
• Common Device Name: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): WELCH ALLYN INC; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 21576758
• Report Number: 1316463-2025-00024
• Device Sequence Number: 8430822
• Product Code: KZF
• UDI-Device Identifier: 00732094072709
• UDI-Public: 732094072709
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2025

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: 48810
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 03/11/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown