MAUDE Adverse Event Report: MIDMARK CORPORATON RITTER 204-001; MANUAL EXAMINATION TABLE

Model Number	204-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	12/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Midmark received awareness from a third-party on september 17, 2020 regarding an incident that allegedly occurred in (b)(6) 2017 resulting in a severe and serious injury to a patient.Based on the information provided, the patient was seated upright, with back unsupported, on a ritter 204-001 manual examination table and underwent a therapeutic phlebotomy procedure.At some point during or after the extended venous phlebotomy procedure, it is reported that the patient was left unattended while feeling sweaty and dizzy, lost consciousness, and fell from the table causing the injury.It was determined that the ritter 204-001 manual examination table did not malfunction nor cause the adverse event to occur, but was being used during the therapeutic phlebotomy procedure when the event occurred.Additional information regarding the product: the intended use of the ritter 204-001, as stated in its instructions for use, is as follows: this product is intended to be used as a table to provide positioning and support of patients during examination procedures conducted by qualified medical professionals in an office environment.Additionally, midmark does offer the ritter 281 blood drawing chair as a device that is intended to provide proper arm and back support to patients during phlebotomy procedures to assist medical professionals in meeting standard guidance's for these types of procedures (i.E.Putting patient in an upright position, monitoring patients for fainting, etc.).
Event or Problem Description
A patient was seated upright on a ritter 204-001 manual examination table with their back unsupported and feet dangling over the side.At some point during or after a therapeutic phlebotomy procedure, the patient informed the nurse that he was experiencing dizziness and was sweaty.The nurse left the room to "get the patient a gatorade", and while the nurse was gone, the patient lost consciousness and fell from the table.The patient sustained severe and serious personal injuries that required medical aid, treatment, and attention.

• Brand Name: RITTER 204-001
• Common Device Name: MANUAL EXAMINATION TABLE
• Manufacturer (Section D): MIDMARK CORPORATON; 60 vista drive; versailles OH 45380
• MDR Report Key: 10684489
• Report Number: 1523530-2020-00003
• Device Sequence Number: 19573634
• Product Code: FRK
• UDI-Device Identifier: 00841709106118
• UDI-Public: 00841709106118
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2020

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: 09/17/2020
• Initial Report FDA Received Date: 10/15/2020
• 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