MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK; LED DENTAL FLEX ARM ASSEMBLY

Model Number	029-5507-00
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 1 event.The 1 event reported to midmark corporation was that the light flex arm holding a monitor detached from the ceiling mount track during adjustment of the device.No patient or injury was involved in this event.Due to previous reporting of this or similar events, midmark corporation complied to report this instance.
Additional Manufacturer Narrative
The device was issued a return authorization to be returned to midmark corporation.Due to the information provided at the time of this report, midmark corporation believes the root cause of this incident is set up error.

• Brand Name: MIDMARK
• Common Device Name: LED DENTAL FLEX ARM ASSEMBLY
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles 45380
• Manufacturer (Section G): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer Contact: sherrinda brumbaugh ; 60 vista drive; versailles, OH 45380
• MDR Report Key: 17340930
• Report Number: 1523530-2023-00003
• Device Sequence Number: 6534098
• Product Code: EAZ
• UDI-Device Identifier: 00841709106903
• UDI-Public: 00841709106903
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/18/2023

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
• Device Model Number: 029-5507-00
• Device Catalogue Number: 1531018 / 153964
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown