D
Patient 1
IT WAS REPORTED TO COVIDIEN THAT THE UNIT HAD A BLANK DISPLAY. COVIDIEN TECHNICIAN FOUND THAT THE UNIT HAD SEGMENTS MISSING IN THE DISPLAY. THERE WAS NO PT INVOLVEMENT.
MAUDE MDR 3963284
- MDR report key
- 3963284
- Report number
- 2936999-2014-00525
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-05-01
- Date received
- 2014-06-18
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- DENISE BRAXTON
- Address
- 6135 GUNBARREL AVE. BOULDER CO 80301 US
- Phone
- 303-303-3038
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-06-18 | 0 |
Event Narratives#
N
Patient 1
COVIDIEN SERVICE CTR REPLACED THE FRONT PCB AND MAIN BOARD. (B)(4). THE SERIAL NUMBER OF THE DISPLAY PCB PRECEDES A CORRECTIVE AND PREVENTIVE ACTION TAKEN BY THE MANUFACTURER.