MAUDE Adverse Event Report: DAO HEALTH FREEMIE PUMP; FREEMIE LIBERTY DELUXE SET

Model Number	FG077
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
None.
Event or Problem Description
On (b)(6) 2018 - customer reported that device was overheating.Device was classified as a "pump not working" per mdr assessment this event was not reportable.On 12/03/2018 - device received by dao health.On 12/12/2018 - device was investigated and found to be "low suction motor and not getting power from the board (did initially, then stopped).Motor runs on the power supply (but only makes about 3 inhg).The board makes 6 volts when measured at the pins but does not run the motor." on 02/04/2019 - during review of the engineering log, engineering decided to review this complaint again and examined the device.Further investigation determined the "q5 chip looks like it might be a little fried".Failure of the q5 chip is the root cause for dao health complaint code "smoking pump".Engineering promptly notified quality so that mdr could be filed.On 02/04/2019 - based on new information, quality began collection information so an mdr could be filed.

• Brand Name: FREEMIE PUMP
• Common Device Name: FREEMIE LIBERTY DELUXE SET
• Manufacturer (Section D): DAO HEALTH; 1345 easy ln; el dorado hills CA 95762
• MDR Report Key: 8384460
• Report Number: 3007602316-2019-00003
• Device Sequence Number: 13522386
• Product Code: HGX
• UDI-Device Identifier: 00851690007455
• UDI-Public: (01)00851690007455(11)180716(10)16.07.18-10
• 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): 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: FG077
• Device Catalogue Number: UPC 730669496752
• Device Lot Number: 16.07.18-10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 03/02/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other