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	Bone Fracture(s) (1870)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On july 2, 2025, midmark corporation was notified of an instance that occurred on or around (b)(6) 2025, in which a nurse was preparing a procedure bed for a patient.While doing so, the model 224 exam table foot control was activated and the table descended onto the nurse's foot causing an alleged break to the right great toe.Midmark corporation has made multiple attempts for further information of this instance with no further details made available.Should further information be given to midmark corporation regarding this instance, a follow up report will be made.
Event or Problem Description
On july 2, 2025, midmark corporation was notified of an instance that occurred on or around (b)(6) 2025, in which a nurse was preparing a procedure bed for a patient.While doing so, the model 224 exam table foot control was activated and the table descended onto the nurse's foot causing an alleged break to the right great toe.Midmark corporation has made multiple attempts for further information of this instance with no further details made available.

• 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: 22635093
• Report Number: 1523530-2025-00005
• Device Sequence Number: 9166766
• Product Code: GBB
• UDI-Device Identifier: 00841709106002
• UDI-Public: 00841709106002
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• 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: Health Professional
• 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: 07/02/2025
• Initial Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2025
• 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