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

Model Number 204-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

Midmark dispatched a certified third party technical service provider for further evaluation of the table.It was determined by the service provider that there was no malfunction of the table or the footstep, and that they were both functioning in combination as intended.After further discussions it was found that the user facility is evaluating their processes for patient entry and exiting of tables.

Event Description

After the patient exam, when stepping down from the exam table onto the footstep, the patient slipped while their feet were on the footstool and fell to the ground.The patient was transported to the emergency department for further evaluation.No further information was provided regarding the status of the patient.

• Brand Name: RITTER 204-001
• Type of Device: MANUAL EXAMINATION TABLE
• Manufacturer (Section D): MIDMARK CORPORATON; 60 vista drive; versailles OH 45380
• Manufacturer (Section G): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer Contact: adam clutter ; 60 vista drive; versailles, OH 45380 ; 9375263662
• MDR Report Key: 8214493
• MDR Text Key: 132049714
• Report Number: 1523530-2018-00002
• Device Sequence Number: 1
• Product Code: FRK
• UDI-Device Identifier: 00841709106118
• UDI-Public: 00841709106118
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 204-001
• Device Catalogue Number: 204-001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other