FDA Adverse Event
Malfunction
Summary report: N
ARC INSTATEMP
MDR report key: 7052290
·
Received November 22, 2017
Report
- Report Number
- 3011197139-2017-00114
- Event Type
- Malfunction
- Date Received
- November 22, 2017
- Date of Event
- November 2, 2017
- Report Date
- November 22, 2017
- Manufacturer
- ARC DEVICES USA INC.
- Product Code
- FLL
- PMA / PMN Number
- K152905
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTS THAT THE THERMOMETER FELL OUT OF THE CABINET AND THAT SHE PICKED UP THE UNIT AND FOUND IT IN PIECES BECAUSE THE BATTERY HAD EXPLODED. NO ONE WAS HURT. ARC REQUESTED THAT THE CUSTOMER RETURN THE PRODUCT. A LAB ANALYSIS FOR THIS TYPE OF FAILURE WAS PERFORMED ON A SIMILAR DEVICE. THE ANALYSIS OF THE BATTERIES INCLUDED AN OPTICAL MICROSCOPY, CT SCAN AND 2D X-RAY AND INDICATED THE FAILURE WAS DUE TO A SINGLE COMPONENT (BATTERY) MALFUNCTION. THE SUSPECT BATTERIES HAVE NOT BEEN USED IN PRODUCTION UNITS SINCE (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 834177 | ARC INSTATEMP | THERMOMETER | FLL | ARC DEVICES USA INC. | CF1-0196 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |