MAUDE Adverse Event Report: MIDMARK CORPORATION RITTER; BARRIER FREE EXAM CHAIR

Model Number	224-002
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On july 10, 2025, midmark corporation was notified of an instance that occurred on or around on (b)(6) 2025, in which cleaning personnel were cleaning a model 224 exam table.While cleaning the table, the foot control was activated and the table descended onto their foot.Midmark corporation has made multiple attempts for further information of the current state of the table and additional details of this instance, although no further details have been made available.
Additional Manufacturer Narrative
On july 10, 2025, midmark corporation was notified of an instance that occurred on or around on (b)(6) 2025, in which cleaning personnel were cleaning a model 224 exam table.While cleaning the table, the foot control was activated and the table descended onto their foot.Midmark corporation has made multiple attempts for further information of the current state of the table and additional details of this instance, although no further details have been made available.Should further information be given to midmark corporation regarding this instance, a follow-up report will be made.

• Brand Name: RITTER
• Common Device Name: BARRIER FREE EXAM CHAIR
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer (Section G): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer Contact: sherrinda brumbaugh ; 60 vista drive; versailles, OH 45380
• MDR Report Key: 22639147
• Report Number: 1523530-2025-00006
• Device Sequence Number: 14750968
• Product Code: GBB
• UDI-Device Identifier: 00841709106002
• UDI-Public: 00841709106002
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 224-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown