MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK; TRACK LIGHT MONITOR

Model Number	029-7245-04
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to midmark corporation that the weldment on a monitor down tube of a dental light broke, and the monitor was suspended by the wire harness.No user or patient involvement or injury reported with this instance.Due to previous reporting of this or similar light falling events, midmark complied to report this instance.
Additional Manufacturer Narrative
At the time of this report, it is known that the monitor down tube weldment was found to be hanging by the wire harness.No user or patient involvement or injury noted in this instance.Since the build date of this device, design correction(s) have been put into place to prevent the failure.The device weldment has been scheduled for service and repair for use.

• Brand Name: MIDMARK
• Common Device Name: TRACK LIGHT MONITOR
• 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 brumbaugh ; 60 vista drive; versailles, OH 45380 ; 9375267990
• MDR Report Key: 20016163
• Report Number: 1523530-2024-00007
• Device Sequence Number: 7448804
• Product Code: EAZ
• UDI-Device Identifier: 00841709107047
• UDI-Public: 00841709107047
• 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: 505
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 08/16/2024

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: 029-7245-04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2017
• 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
• Patient Sex: Unknown