MAUDE Adverse Event Report: HILL-ROM MEXICO GS-300 GEN EXAM LT W/MOBILE STD DOM; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number	44400
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that unit has pulled from the base and has exposed wiring.There were no injuries caused by the reported event.This complaint was captured under hillrom ref # (b)(4).
Additional Manufacturer Narrative
The welch allyn gs 300 is an exam light, 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 300 light is mounted on a mobile stand or table/wall mount.To prevent injury from exposed wires and damaged housing, there are warnings in the dfu including: inspect the device for wear, fraying, or other damage.Do not use if you see signs of damage, if the instrument malfunctions, appears not to be working properly, or if you notice a change in performance.The reported problem of physical damage has been verified.Device failed functional check.The problem is with the gooseneck assembly of light.Although the reported event did not result in a serious injury to the customer or the patients, a report of exposed wires could result in electrical injury if it was to recur.Therefore, hillrom consider this event reportable.Based on the information provided at this time no further action is required.

• Brand Name: GS-300 GEN EXAM LT W/MOBILE STD DOM
• Common Device Name: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col.; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 19718805
• Report Number: 3006087789-2024-00002
• Device Sequence Number: 18215246
• Product Code: KZF
• UDI-Device Identifier: 00732094074109
• UDI-Public: 732094074109
• 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): 07/11/2024

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: 44400
• Device Lot Number: 2227
• 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: 06/17/2024
• Initial Report FDA Received Date: 07/11/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown