MAUDE Adverse Event Report: VEGA TECHNOLOGIES / DICKSON ASIA GROUP, LTD. PORTABLE AC/DC SUCTION MACHINE

Model Number	SU100DC
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The patient reported one unit of su100dc that started smoking while using the unit.No report of injury was received.Evidence shows that the unit burnt out.

• Brand Name: PORTABLE AC/DC SUCTION MACHINE
• Common Device Name: SUCTION MACHINE
• Manufacturer (Section D): VEGA TECHNOLOGIES / DICKSON ASIA GROUP, LTD.; yangwu district, dalong town; dongguan city, 52378 9; CH 523789
• Manufacturer (Section G): VEGA TECHNOLOGIES / DICKSON ASIA GROUP, LTD.; yangwu district, dalong town; dongguan city, 52378 9; CH 523789
• Manufacturer Contact: yangwu district, dalong town; dongguan city, 52378-9
• MDR Report Key: 16689225
• Report Number: 3006446479-2023-00001
• Device Sequence Number: 17622633
• Product Code: LRQ
• UDI-Device Identifier: 00848530088965
• UDI-Public: (01)00848530088965
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2023

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: Lay User/Patient
• Device Model Number: SU100DC
• Device Catalogue Number: SU100DC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (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