MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK DENTAL LIGHT-LED, CEILING MOUNT; LED DENTAL LIGHT

Model Number 153905-002

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2024

Event Type  malfunction  

Event Description

Midmark received a complaint of a light head post of a ceiling mounted led dental light reported to have come loose causing the post, and presumably also the light, to fall.No injury to patient or staff was involved.Due to previous reporting of this or similar light falling events, midmark complied to report this instance.

Manufacturer Narrative

No return was issued for the device involved in this event.Due to the information provided at the time of this report, midmark corporation believes the root cause of this event is set up error.

• Brand Name: MIDMARK DENTAL LIGHT-LED, CEILING MOUNT
• Type of Device: LED DENTAL LIGHT
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer (Section G): MIDMARK CORPORATION; 60 vista drive; verailles OH 45380
• Manufacturer Contact: sherrinda brumbaugh ; 60 vista drive; versailles, OH 45380
• MDR Report Key: 19104706
• MDR Text Key: 340903841
• Report Number: 1523530-2024-00001
• Device Sequence Number: 1
• Product Code: EAZ
• UDI-Device Identifier: 00841709107405
• UDI-Public: 00841709107405
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 04/10/2024

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 Operator: Health Professional
• Device Model Number: 153905-002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2021
• 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