FDA Adverse Event
Other
Summary report: N
E500 VENTILATOR
MDR report key: 1145605
·
Received August 27, 2008
Report
- Report Number
- 2023050-2008-00060
- Event Type
- Other
- Date Received
- August 27, 2008
- Date of Event
- July 26, 2008
- Report Date
- July 29, 2008
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(BURNED BOARD)
Description of Event or Problem · 1
REPORTEDLY, SMOKE CAME OUT FROM BACK SITE OF THE GDM (GRAPHICS DISPLAY MONITOR) WHILE THE UNIT WAS RUNNING ON A PT AT ICU. THE SCREEN WAS VANISHED WITH AUDIBLE ALARM. THE HOSPITAL STAFF CONFIRMED THAT THE UNIT WAS WORKING NORMALLY AND THE PT WAS SAFE. THE PT WAS MANUALLY VENTILATED AND THEN SWITCHED TO ANOTHER UNIT. VISUAL EXAMINATION OF BOARD (PCB1911A) BY THE DISTRIBUTOR FOUND A BURNED TRACE. PLEASE NOTE THAT THERE WERE NO SERIOUS INJURIES OR DEATH IN THIS CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | E500 VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | E500 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |