MAUDE Adverse Event Report: SEDECAL SA KONICA MINOLTA; GENERATOR, HIGH-VOLTAGE, X-RAY, DIAGNOSTIC

Model Number	SHFR-500
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Technologist stated they were imaging a patient thought they heard a pop after the last image.They let the patient go and left the room they came back in and smelled smoke than they saw a flame come out of the generator they killed the power and evacuated the building and called the fire department the fire department cut all the cables to the generator and moved the generator out of the building.No injury was reported.The generator caught fire.

• Brand Name: KONICA MINOLTA
• Common Device Name: GENERATOR, HIGH-VOLTAGE, X-RAY, DIAGNOSTIC
• Manufacturer (Section D): SEDECAL SA; pelaya, 9 .; pol. ind. rio de janeiro; algete, madrid 28110 ; SP 28110
• Manufacturer (Section G): SEDECAL SA; pelaya, 9 .; pol. ind. rio de janeiro; algete, madrid 28110 ; SP 28110
• Manufacturer Contact: maria gomez ; pelaya, 9 .; pol. ind. rio de janeiro; algete, madrid 28110 ; SP 28110
• MDR Report Key: 16618332
• Report Number: 9617251-2023-00002
• Device Sequence Number: 6093985
• Product Code: IZO
• UDI-Device Identifier: 08436046001374
• UDI-Public: 08436046001374
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2023

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: SHFR-500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2018
• 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