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

Model Number 029-4857-00

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 03/29/2019

Event Type  malfunction  

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 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
• 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: 8607907
• MDR Text Key: 145112875
• Report Number: 1523530-2019-00002
• Device Sequence Number: 1
• Product Code: EAZ
• UDI-Device Identifier: 00841709106897
• UDI-Public: 00841709106897
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 029-4857-00
• Device Catalogue Number: 153963
• 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