MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK; 255 DUAL CEILING LIGHT

Model Number 255-023

Device Problem Device Fell (4014)

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

Event Date 08/10/2023

Event Type  malfunction  

Manufacturer Narrative

Midmark corporation has requested that the light be returned for evaluation, and a servicer has been dispatched to replace a new light within the facility.At the time of this report, midmark corporation has received the returned light.

Event Description

This report summarizes 1 event.The 1 event reported to midmark corporation was that a light arm of a dual ceiling light detached at the ball joint and fell.No patient or injury was involved in this event.Due to reporting of this or similar events, midmark corporation complied to report this instance.

• Brand Name: MIDMARK
• Type of Device: 255 DUAL CEILING 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: 17789969
• MDR Text Key: 323944836
• Report Number: 1523530-2023-00004
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 255-023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Date Manufacturer Received: 08/10/2023
• Date Device Manufactured: 12/05/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1