MAUDE Adverse Event Report: EMG TECHNOLOGY CO. LTD. DRIVE MEDICAL; SUCTION MACHINE

Model Number	18600
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	03/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare received a notification from an attorney of an incident involving a suction machine that drive imports and distributes.The patient was sleeping with the suction machine next to his bed when allegedly he got burnt.He was taken to the hospital where it was discovered he had suffered a 2nd degree burn from touching the unit.

• Brand Name: DRIVE MEDICAL
• Common Device Name: SUCTION MACHINE
• Manufacturer (Section D): EMG TECHNOLOGY CO. LTD.; no. 58 gongyequ 35th road; xitun district; taichung city, taiwan 40768 ; TW 40768
• MDR Report Key: 6847027
• Report Number: 2438477-2017-00074
• Device Sequence Number: 633343
• Product Code: JCX
• UDI-Device Identifier: 00822383151649
• UDI-Public: 00822383151649
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 07/24/2017
• Report Date (Section F): 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 18600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/09/2017
• Event Location: Home
• Date Report to Manufacturer: 09/06/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 9 YR
• Date Report Sent to FDA: 09/06/2017