FDA Adverse Event
Malfunction
Summary report: N
DRX MOBILE REVOLUTION
MDR report key: 6090458
·
Received November 9, 2016
Report
- Report Number
- 1317307-2016-00010
- Event Type
- Malfunction
- Date Received
- November 9, 2016
- Date of Event
- November 3, 2016
- Report Date
- December 8, 2016
- Manufacturer
- CARESTEAM HEALTH INC
- Product Code
- IZL
- PMA / PMN Number
- K041783
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION OF THIS INCIDENT IS STILL ONGOING. CARESTREAM HEALTH WILL SUBMIT A FOLLOW UP REPORT WITHIN THE REQUIRED TIMEFRAME FOR REPORTING.
Additional Manufacturer Narrative · 1
CARESTREAM HEALTH IS INVESTIGATING THIS ISSUE AND WILL SUBMIT A FOLLOW UP REPORT WITHIN THE REQUIRED TIMEFRAME. THE DEVICE IS IN THE PROCESS OF BEING EVALUATED FOR ROOT CAUSE.
Description of Event or Problem · 1
CUSTOMER ALLEGES THAT THE DRX REVOLUTION HAD A THERMAL EVENT. THIS EVENT WAS CONTAINED TO THE DEVICE ONLY AND THERE WERE NO INJURIES.
Description of Event or Problem · 1
CUSTOMER ALLEGES THAT THE DRX REVOLUTION HAD A THERMAL EVENT. THIS EVENT WAS CONTAINED TO THE DEVICE ONLY AND THERE WERE NO INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 739469 | DRX MOBILE REVOLUTION | DRX REVOLUTION | IZL | CARESTEAM HEALTH INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |