MAUDE Adverse Event Report: DAO HEALTH INDEPENDENCE DELUXE SET

Model Number	FG076
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 06-07-2018 - pump was received by customer and is being inspected to determine cause.On 06-25-2018 - preliminary investigation completed.The pump was returned opened with the motor disconnected from the control board.No visual observations noticed upon initial visual inspection.The motor was plugged back in and the pump was turned on.The motor was not cycling on and off as it should normally with each suction and release cycle, it was continuously running.When the pump was turned off the motor continued to run.When the pump was turned back on the q5 transistor began to smoke for a few seconds until the board and motor ceased to operate.There were no visible flames.Since the board was no longer operational the motor was plugged into another pump control board.The motor displayed the same behavior and the same chip began to smoke until the board was no longer operational.No flames were visible.The motor was used with another board in order to measure the temperature of the motor and the chip when smoking.The maximum motor temperature was measured to be 176.5 f and the maximum chip temperature when smoking was 322 f.No flames were visible.Based on the above investigation there seems to be some type of malfunction of the motor.The motor is being sent back to the motor supplier for further investigation.There were no visible flames from the chip on the control board, however, the chip did smoke, and the control board/pump was no longer operational.The maximum temperature seen by the chip was 322 f which is not hot enough to cause any type of fire.
Event or Problem Description
On (b)(6) 2018 - the customer reported her pump started smoking.On (b)(6) 2018 - during customer service's call the customer reported "smoke came from the pump port, the pump was fully charged, she was sitting on sofa when in use, after 10 minutes the pump started to smoke." the customer also noted that she took pump apart to try to identify where the smoke was coming from.

• Brand Name: INDEPENDENCE DELUXE SET
• Common Device Name: INDEPENDENCE DELUXE SET
• Manufacturer (Section D): DAO HEALTH; 1345 easy ln; el dorado hills CA 95762
• MDR Report Key: 7701515
• Report Number: 3007602316-2018-00002
• Device Sequence Number: 16512738
• Product Code: HGX
• UDI-Device Identifier: 00851690007448
• UDI-Public: 00851690007448
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2018

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: FG076
• Device Catalogue Number: UPC 730669496745
• Device Lot Number: 04.12.17-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 07/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other