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

Model Number	SHF-835
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient involved: no.No patient was in room when technologist saw smoke.Injuries: no.Technologist left room so no injury.Issue: on (b)(6) 2023 around 6:19pm the technologist was taking a break and when he can back into the room the generator was smoking it triggered the fire alarm so the fire department came and had to put out the fire by a fire extinguisher.The site cut all wires from the generator and removed it from the room.

• 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: 16581992
• Report Number: 9617251-2023-00001
• Device Sequence Number: 20003875
• Product Code: IZO
• UDI-Device Identifier: 08436046000438
• UDI-Public: 08436046000438
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2023

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: SHF-835
• 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: 03/21/2023
• 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