MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK ULTRA TRIM DENTAL CHAIR

Model Number	153758-003
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes an event that was reported to midmark on (b)(6), 2023 in which it was stated that the back of a dental chair detached from the base with a patient in the chair.No injury was reported.Per service note, the shoulder bolts that hold the backrest, at the side of the chair, behind the touch pad controls appeared loose.

• Brand Name: MIDMARK ULTRA TRIM DENTAL CHAIR
• Common Device Name: ULTRA TRIM DENTAL CHAIR
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles 45380
• Manufacturer (Section G): MIDRMARK CORPORATION; 60 vista drive; versailles OH 45304
• Manufacturer Contact: sherrinda brumbaugh ; 60 vista drive; versailles, OH 45380 ; 9375267990
• MDR Report Key: 17790004
• Report Number: 1523530-2023-00005
• Device Sequence Number: 14994961
• Product Code: NRU
• UDI-Device Identifier: 00841709108976
• UDI-Public: 00841709108976
• Combination Product (Y/N): N
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 153758-003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2020
• 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