FDA Adverse Event
Other
Summary report: N
E100 VENTILATOR
MDR report key: 1360421
·
Received April 1, 2009
Report
- Report Number
- 2023050-2009-00008
- Event Type
- Other
- Date Received
- April 1, 2009
- Date of Event
- March 3, 2009
- Report Date
- March 3, 2009
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K972833
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO DEVICE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
REPORTEDLY, DURING USE ON A PATIENT NO ALARM OCCURRED WHEN THE VENTILATOR PRESSURE RAISED ONLY 5CMH2O INSTEAD OF 17CMH2O, PREVENTING THE PATIENT'S LUNG FROM INFLATING ADEQUATELY. PLEASE NOTE THAT THERE WAS NO SERIOUS INJURY IN THIS CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | E100 VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | E100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |