FDA Adverse Event
Malfunction
Summary report: N
NUK SIMPLY NATURAL FREEMIE COLLECTION CUPS
MDR report key: 8002909
·
Received October 24, 2018
Report
- Report Number
- 3007602316-2018-00004
- Event Type
- Malfunction
- Date Received
- October 24, 2018
- Date of Event
- September 22, 2018
- Report Date
- October 23, 2018
- Manufacturer
- DAO HEALTH
- Product Code
- HGX
- PMA / PMN Number
- K172772
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 842778 | NUK SIMPLY NATURAL FREEMIE COLLECTION CUPS | NUK SIMPLY NATURAL FREEMIE COLLECTION CUPS | HGX | DAO HEALTH | FG078 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |