FDA Adverse Event
Summary report: N
E360 VENTILATOR
MDR report key: 2132250
·
Received June 3, 2011
Report
- Report Number
- 2023050-2011-00022
- Date Received
- June 3, 2011
- Date of Event
- April 29, 2011
- Report Date
- May 9, 2011
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K053502
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(6).
Description of Event or Problem · 1
REPORTEDLY, THE LCD DISPLAY ON THE VENTILATOR AND THE EXTERNAL TOUCH SCREEN MONITOR LOST THE PICTURE WHILE THE VENTILATOR CONTINUED WORKING NORMALLY ON A PT. AS A PRECAUTIONARY MEASURE, THE PT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED. PLEASE NOTE THAT THERE WAS NO PT INJURY IN THIS CASE. LATER, THE DISTRIBUTOR CHECKED THE VENTILATOR; HOWEVER, NO PROBLEM WAS FOUND. THE VENTILATOR FUNCTIONED NORMALLY.
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 | 62 YR | Required Intervention | NO |