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

Model Number	255-023
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Event or Problem Description
The original submission, mfg report # 1523530-2023-00004 submitted sept.21, 2023, summarized 1 event reported to midmark corporation 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.
Additional Manufacturer Narrative
At the time of the intial report of this instance, the light had not been returned to midmark corporation.Since that time, the light has been returned, evaluated, and a formal investigation has been performed.Results from the investigation confirmed that the process change to this device that has been put in place will prevent this failure.No further action is necessary.

• Brand Name: MIDMARK
• Common Device Name: 255 DUAL CEILING LIGHT
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer (Section G): MIDMARK CORPORATION; 60 vist drive; versailles OH 45380
• Manufacturer Contact: sherrinda brumbaugh ; 60 vista drive; versailles, OH 45380
• MDR Report Key: 17789969
• Report Number: 1523530-2023-00004
• Device Sequence Number: 17705409
• Product Code: KZF
• UDI-Device Identifier: 00841709106828
• UDI-Public: 00841709106828
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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 Model Number: 255-023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2017
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown