FDA Adverse Event
Malfunction
Summary report: N
E360 VENTILATOR
MDR report key: 1972637
·
Received January 19, 2011
Report
- Report Number
- 2023050-2011-00003
- Event Type
- Malfunction
- Date Received
- January 19, 2011
- Date of Event
- December 10, 2010
- Report Date
- December 27, 2010
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K053502
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
REPORTEDLY WHEN A MEDICAL ENGINEER AT THE HOSPITAL DISCONNECTED AC CABLE IN ORDER TO CHECK A BATTERY FUNCTION WHILE THE VENTILATOR WAS RUNNING, THE VENTILATOR DID NOT SWITCH TO BATTERY POWER AND SHUTDOWN SUDDENLY WITHOUT ALARMING DUE TO LOW BATTERY. PLEASE NOTE THAT THERE WAS NO PT INVOLVEMENT IN THIS CASE. HOWEVER, IF IT WERE TO RECUR ON A PT, THE VENTILATOR WOULD NOT HAVE GIVEN AN ENOUGH TIME OF WARNING TO TAKE APPROPRIATE ACTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | E360 VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | E360 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |