MAUDE Adverse Event Report: SKYTRON SKYTRON FREEDOM; HEAVY DUTY MONITOR MOUNT

Model Number	4FXS-60
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is within scope of active recall event 96581.Field correction activities had not been completed yet at the time of the failure.
Event or Problem Description
Skytron authorized representative submitted a complaint on 7/24/2025 describing an incident where a ge display detached from a skytron 4fsx-60 heavy duty monitor mount.Per the details provided in the complaint report, the incident occurred overnight with no patient or staff injury or involvement.

• Brand Name: SKYTRON FREEDOM
• Common Device Name: HEAVY DUTY MONITOR MOUNT
• Manufacturer (Section D): SKYTRON; 5085 corporate exchange blvd s; grand rapids MI 49512
• Manufacturer (Section G): IHB OPERATIONS; ceintuurbaan 15b2; zwolle, overijssel 8022 AW; NL 8022 AW
• Manufacturer Contact: lex hejna ; 5085 corporate exchange bldvd se; grand rapids, MI 49512 ; 6166562900
• MDR Report Key: 22874917
• Report Number: 1825014-2025-00003
• Device Sequence Number: 21425490
• Product Code: FQO
• UDI-Device Identifier: 10841736116286
• UDI-Public: (01)10841736116286
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

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
• Operator of Device: Health Professional
• Device Model Number: 4FXS-60
• Device Catalogue Number: 4FXS-60
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2022
• 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