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

Model Number	029-4857-00
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 flex arm assembly broke causing the monitor to fall.The weld breaking is likely the result of a manufacturing defect, and a replacement flex arm assembly was sent to the user facility.
Event or Problem Description
The user facility discovered the dental monitor hanging by the wires and the down tube that holds the monitor broken.No injuries were reported.

• Brand Name: MIDMARK DENTAL TRACK LIGHT MONITOR
• Common Device Name: LIGHT, OPERATING, DENTAL
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• MDR Report Key: 8607907
• Report Number: 1523530-2019-00002
• Device Sequence Number: 1685505
• Product Code: EAZ
• UDI-Device Identifier: 00841709106897
• UDI-Public: 00841709106897
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/13/2019

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: 029-4857-00
• Device Catalogue Number: 153963
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1