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

Model Number 029-4856-00

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 09/19/2019

Event Type  malfunction  

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 2019.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 flex arm assembly broke causing the monitor to fall.A replacement flex arm assembly was sent to the user facility.

Event Description

This report summarizes malfunction event.The 1 event stated the monitor flex arm broke and the light was found hanging by its wires.The 1 event reported no patient or user injury.

• Brand Name: MIDMARK DENTAL TRACK LIGHT MONITOR
• Type of Device: LIGHT, OPERATING, DENTAL
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer (Section G): MIDMARK CORPORATION; 60 vista dr.; versailles OH 45380
• Manufacturer Contact: adam clutter ; 60 vista dr.; versailles, OH 45380 ; 9375268474
• MDR Report Key: 9260343
• MDR Text Key: 196250617
• Report Number: 1523530-2019-00004
• Device Sequence Number: 1
• Product Code: EAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 029-4856-00
• Device Catalogue Number: 153830-003
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1