FDA Adverse Event
Other
Summary report: N
EVERGO OXYGEN CONCENTRATOR
MDR report key: 2845036
·
Received November 8, 2012
Report
- Report Number
- 1040777-2012-00025
- Event Type
- Other
- Date Received
- November 8, 2012
- Date of Event
- October 15, 2012
- Report Date
- October 15, 2012
- Manufacturer
- RESPIRONICS INC.
- Product Code
- CAW
- PMA / PMN Number
- K043615
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVERGO OXYGEN CONCENTRATOR'S DC ADAPTOR WAS HOT TO THE TOUCH AND BURNED A PATIENT'S FINGER. THE PATIENT WAS USING THE DC ADAPTOR IN A CAR WHEN THEY UNPLUGGED THE ADAPTOR FROM THE CAR DC OUTLET, THEY ALLEGEDLY RECEIVED A BURN. THE BURN REPORTEDLY BECAME INFECTED AND THE PATIENT REQUIRED ANTIBIOTICS TO TREAT THE INFECTION. THE DEVICE HAS YET TO BE RETURNED FOR AN EVALUATION BY THE MANUFACTURER. A FOLLOW UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EVERGO OXYGEN CONCENTRATOR | GENERATOR, OXYGEN, PORTABLE | CAW | RESPIRONICS INC. | 900-000-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |