MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK; LED DENTAL LIGHT

Model Number	153905-002
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Midmark corporation received a complaint of a dental light head post of a ceiling mounted led dental light reported to have come loose causing the post, and consequently the light, to fall.No injury to patient or staff was involved.Due to previous reporting of this or similar incidents, midmark corporation complied to regulatory requirements and reported this event accordingly.
Additional Manufacturer Narrative
Service parts identified for device.Midmark corporation believes the root cause of this event is set up error.

• Brand Name: MIDMARK
• Common Device Name: LED DENTAL LIGHT
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer (Section G): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer Contact: sherrinda brumbaugh ; 60 vista drive; versailles, OH 45380
• MDR Report Key: 19236642
• Report Number: 1523530-2024-00003
• Device Sequence Number: 8072125
• Product Code: EAZ
• UDI-Device Identifier: 00841709107405
• UDI-Public: 841709107405
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 05/03/2024

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
• Device Model Number: 153905-002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown