MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK TRACK LIGHT MONITOR; LIGHT, OPERATING, DENTAL

Model Number	029-4739-02
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is a consolidation of reports summarized as part of the fda voluntary malfunction summary reporting program.1 event was reported in quarter 3 of 2020.The 1 event did not have patient or user involvement, and did not result in injury.At the time of this report, a physical investigation could not be completed due to the device being unavailable for evaluation.However, after reviewing pictures provided by the user facility it appears that a weld on the downtube causing the monitor to fall.A replacement downtube was sent to the user facility.
Event or Problem Description
This report summarizes 1 malfunction event.The 1 event stated the weld broke on monitor mount down tube and monitor was found hanging on by its wires.The 1 event reported no patient, or user injury, it broke between patients.

• Brand Name: MIDMARK TRACK LIGHT MONITOR
• Common Device Name: LIGHT, OPERATING, DENTAL
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• MDR Report Key: 10626834
• Report Number: 1523530-2020-00002
• Device Sequence Number: 2631387
• Product Code: EAZ
• UDI-Device Identifier: 00841709106880
• UDI-Public: 00841709106880
• 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): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2020

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: No Information
• Device Model Number: 029-4739-02
• Device Catalogue Number: 153963/153964
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1