MAUDE Adverse Event Report: IHB OPERATIONS FREEDOM; LIGHT DUTY DUAL MONITOR MOUNT

Model Number	4FVB-2
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Determined that 4fvb-2 was assembled incorrectly.The m6x20 and m6x14 bolts were installed in the incorrect locations which resulted in an insufficient connection between the support beam and the base.
Event or Problem Description
Skytron authorized representative submitted a complaint on (b)(6) 2026 describing an incident where a 4fvb-2 monitor bracket detached from the vertical support tube.Per the details provided in the complaint report, there were no injuries to patient or staff as a result of the incident.

• Brand Name: FREEDOM
• Common Device Name: LIGHT DUTY DUAL MONITOR MOUNT
• Manufacturer (Section D): IHB OPERATIONS; ceintuurbaan 15b2; zwolle, overijssel 8022 AW; NL 8022 AW
• Manufacturer (Section G): IHB OPERATIONS; ceintuurbaan 15b2; zwolle, overijssel 8022 AW; NL 8022 AW
• Manufacturer Contact: lex hejna ; 5085 corporate exchange blvd se; grand rapids, MI 49512 ; 6166562900
• MDR Report Key: 24433779
• Report Number: 1825014-2026-00001
• Device Sequence Number: 18703243
• Product Code: FQO
• UDI-Device Identifier: 10841736115951
• UDI-Public: 10841736115951
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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
• Operator of Device: Health Professional
• Device Model Number: 4FVB-2
• Device Catalogue Number: 4FVB-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2023
• 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