MAUDE Adverse Event Report: DAO HEALTH NUK SIMPLY NATURAL FREEMIE COLLECTION CUPS

Model Number FG078

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2018

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2018 - pump was received by customer and investigation was conducted.On (b)(6) 2018 - investigation completed.Device was investigation and investigation determined that q5 chip on the board was burnt out.This event has previously been reported and investigated.

Event Description

On (b)(6) 2018 - customer reported that pump motor started to burn up.The screen on the bottom right corner turned black from motor getting so hot.

• Brand Name: NUK SIMPLY NATURAL FREEMIE COLLECTION CUPS
• Type of Device: NUK SIMPLY NATURAL FREEMIE COLLECTION CUPS
• Manufacturer (Section D): DAO HEALTH; 1345 easy ln; el dorado hills CA 95762
• Manufacturer (Section G): WREX PRODUCTS; 25 wrex ct; chico CA 95928
• Manufacturer Contact: dave paul ; 1345 easy ln.; el dorado hills, CA 95762 ; 9163397388
• MDR Report Key: 8002909
• MDR Text Key: 124985984
• Report Number: 3007602316-2018-00004
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2018

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
• Device Operator: Lay User/Patient
• Device Model Number: FG078
• Device Catalogue Number: UPC 730669496769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other