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

Model Number 029-4739-00

Device Problem Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2017

Event Type  malfunction  

Manufacturer Narrative

At the time of the report, an investigation could not be completed due to not having the device available to investigate.

Event Description

A monitor fell from a midmark dental light mount into an empty chair next to a patient.No injuries were reported.

• Brand Name: MIDMARK
• Type of Device: TRACK LIGHT MONITOR MOUNT
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista dr.; 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: 6296996
• MDR Text Key: 66660096
• Report Number: 1523530-2017-00001
• 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): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 029-4739-00
• Device Catalogue Number: 153829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2013
• 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