MAUDE Adverse Event Report: MIDMARK CORPORATION RITTER BARRIER FREE EXAM CHAIR; EXAM CHAIR, PRODUCT CODE GBB

Model Number	225-002
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided within the service record of this incident, the table did not malfunction in this instance.The instruction for use (ifu) has a warning that all personnel and equipment are to be a minimum of 6" from the table before activating any function.
Event or Problem Description
This report summarizes an event that occurred on or around (b)(6) 2022, in which it was stated that a nurse had the foot control right in front of the chair base while lowering the base and did not remove her foot from the control when lowering the chair.The shrouds lowered onto her toe and fractured her toe.

• Brand Name: RITTER BARRIER FREE EXAM CHAIR
• Common Device Name: EXAM CHAIR, PRODUCT CODE GBB
• 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 baker ; 60 vista drive; versailles, OH 45380
• MDR Report Key: 15438015
• Report Number: 1523530-2022-00001
• Device Sequence Number: 5973298
• Product Code: GBB
• UDI-Device Identifier: 00841709105975
• UDI-Public: 00841709105975
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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: 225-002
• Device Catalogue Number: 225-002
• 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: 08/25/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2021
• 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