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

Model Number 029-5507-00

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 319289016
• Report Number: 1523530-2023-00003
• Device Sequence Number: 1
• Product Code: EAZ
• UDI-Device Identifier: 00841709106903
• UDI-Public: 00841709106903
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1