MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK; 255 PROCEDURE L IGHT

Model Number	255-021
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Midmark dispatched a servicer to the facility to evaluate, repair, and perform any necessary maintenance on other lights that were within the facility.A new light was installed in place of the light with which the instance occurred.At the time of this report, midmark had requested for the product to be returned and had not received it.
Event or Problem Description
This report summarizes 1 malfunction event that occurred on or about (b)(6) 2021 per notice to midmark.It was stated that a model 255 procedure light head fell from the ceiling due to stripped or broken bolts.No injury was reported with this instance.
Event or Problem Description
This report summarizes 1 malfunction event that occurred on or about (b)(6) 2021 per notice to midmark.It was stated that a model 255 procedure light head fell from the ceiling due to stripped or broken bolts.No injury was reported with this instance.
Additional Manufacturer Narrative
Midmark dispatched a servicer to the facility to evaluate, repair, and perform any necessary maintenance on other lights that were within the facility.A new light was installed in place of the light with which the instance occurred.At the time of this report, midmark had requested for the product to be returned and had not received it.

• Brand Name: MIDMARK
• Common Device Name: 255 PROCEDURE L IGHT
• 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 baker ; 60 vista drive; versailles, OH 45380 ; 9375267990
• MDR Report Key: 12679906
• Report Number: 1523530-2021-00003
• Device Sequence Number: 3572279
• Product Code: KZF
• UDI-Device Identifier: 00841709106804
• UDI-Public: 00841709106804
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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
• Operator of Device: Health Professional
• Device Model Number: 255-021
• Device Catalogue Number: 255-021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2017
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown