MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK; LIGHT FLEX ARM ASSEMBLY

Model Number	029-4857-00
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information has been provided to midmark corporation regarding this instance at the time of this report.Since the build date of this device, design correction(s) have been put into place to prevent the failure.If further information is provided, a follow up report will be made if necessary.
Event or Problem Description
It was reported to midmark corporation that on (b)(6) 2025, a light flex arm assembly fell from its trolley.No injury has been reported.Due to previous reporting of like instances, midmark corporation complied to report this instance.

• Brand Name: MIDMARK
• Common Device Name: LIGHT FLEX ARM ASSEMBLY
• 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: 22830877
• Report Number: 1523530-2025-00007
• Device Sequence Number: 4463779
• Product Code: EAZ
• UDI-Device Identifier: 00841709106897
• UDI-Public: 00841709106897
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2025

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: 029-4857-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2012
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown