MAUDE Adverse Event Report: MIDMARK CORPORATION RITTER 204 MANUAL EXAMINATION TABLE

Model Number	204-001
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Midmark received a phone call from a third party organization on april 17, 2020 regarding an incident of a patient that occurred in (b)(6) 2019 that resulted in an injury to the patient's shoulder and neck.Midmark attempted to get the user facility's contact information from the third party in order to get additional information about the event, but contact information was not provided.Additionally, the table was not made available to midmark for further investigation.Based on the information that was provided, it is thought that the patient likely stepped toward the side of the footstep as they were getting off of the table and their foot slipped.The steps are designed to be steady and sturdy when weight is applied to them.Rubber bumpers on the step assembly come in contact with the floor on both front corners of the step ensuring stability when weight is applied.This also keeps the step from moving in or out by compressing the wheel mechanism to ensure the step sits flush to the floor to support the patient's weight as they egress from the table.Based on the information provided regarding the event, it appears there was no malfunction of the table or the footstep.
Event or Problem Description
After a patient exam, when stepping down from the 204 examination table onto the footstep, the patient's foot slipped off the side of the step causing the patient to fall to the ground on their shoulder resulting in an injury to the patient's shoulder and neck.

• Brand Name: RITTER 204 MANUAL EXAMINATION TABLE
• Common Device Name: MANUAL EXAMINATION TABLE
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vitsa drive; versailles, oh
• MDR Report Key: 10059462
• Report Number: 1523530-2020-00001
• Device Sequence Number: 3083393
• Product Code: FRK
• UDI-Device Identifier: 00841709106118
• UDI-Public: 00841709106118
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 204-001
• Device Catalogue Number: 204-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other