MAUDE Adverse Event Report: MIDMARK CORPORATION RITTER; MEDICAL EXAM TABLE

Model Number 104-035

Device Problem Insufficient Information (3190)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

Upon review of medwatch form mw5113861, an investigation yielded the medical exam table involved in this event reached end of service life december 16, 2016 as documented and issued to customers in november of 2016.Midmark cannot confirm the stated malfunction.The design of this feature has been discontinued; however, testing was performed on the comparable design, which did not confirm a possible failure of this nature.Customer advised midmark that the table was removed from service.

Event Description

This report is in response to medwatch report mw5113861, received by midmark corporation on december 30, 2022.The stated event from the received report reads, "patient received a burn when a vaginal speculum was removed from healing drawer in exam table.Patient quickly alerted provider of warmth of instrument and instrument was removed.Table was turned off and equipment removed.The exam table is a ritter model 104 purchased in feb 2001, asset # (b)(4).Tables are inspected annually, next due for inspection feb 2023.The temperature of drawer was reported to be 200 degrees f.".

• Brand Name: RITTER
• Type of Device: MEDICAL EXAM TABLE
• 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: 16282585
• MDR Text Key: 308717190
• Report Number: 1523530-2023-00001
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 12/16/2016
• Device Model Number: 104-035
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/1997
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other