MAUDE Adverse Event Report: MIDMARK CORP. MIDMARK; LIGHT, OPERATING, DENTAL

Model Number 18600

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 08/11/2014

Event Type  malfunction  

Event Description

While a pt was under the light, the light fell off and landed on the pt.No injuries were sustained.

Manufacturer Narrative

At the time of the report, an investigation could not be completed into the cause of failure.A follow-up report will be submitted with further info.

• Brand Name: MIDMARK
• Type of Device: LIGHT, OPERATING, DENTAL
• Manufacturer (Section D): MIDMARK CORP.; versailles OH
• Manufacturer Contact: craig rammel ; 60 vista dr.; versailles, OH 45380 ; 9375263662
• MDR Report Key: 4177364
• MDR Text Key: 5162486
• Report Number: 1523530-2014-00014
• Device Sequence Number: 1
• Product Code: EAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 18600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• 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
• Patient Outcome(s): Other