FDA Adverse Event
Death
Summary report: N
E500 VENTILATOR
MDR report key: 3565141
·
Received January 6, 2014
Report
- Report Number
- 2023050-2013-00916
- Event Type
- Death
- Date Received
- January 6, 2014
- Date of Event
- December 9, 2013
- Report Date
- December 11, 2013
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K061094
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
REPORTEDLY, DURING PATIENT USE, THE VENTILATOR STOPPED CYCLING AND A 'DEVICE ALERT' ALARM OCCURRED. THE PT WAS MANUALLY VENTILATED; HOWEVER THE PT DIED. PER THE PHYSICIAN'S OPINION, IT COULD NOT BE CONFIRMED IF THE PATIENT'S DEATH WAS LIKED TO THE STOPPING OF THE VENTILATOR. COVIDIEN IS WORKING ON GETTING THE DEVICE BACK FOR FAILURE INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 7374 | E500 VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | E500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Death |