FDA Adverse Event
Malfunction
Summary report: N
E360 VENTILATOR
MDR report key: 1881291
·
Received October 18, 2010
Report
- Report Number
- 2023050-2010-00043
- Event Type
- Malfunction
- Date Received
- October 18, 2010
- Report Date
- September 20, 2010
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K053502
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EC
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO DEVICE RETURNED TO MFR FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTILATOR STOPPED WHILE IN USE ON A HOSPITALIZED PT AND THE VENTILATOR WAS RESTARTED. IT IS NOT KNOWN IF THE APPROPRIATE ALARMS WERE ALERTED. NO FURTHER INFO WAS PROVIDED CONCERNING THIS EVENT. IT IS NOT KNOWN IF ANY MEDICAL INTERVENTION WAS REQUIRED. NO ADD'L INFO WAS PROVIDED REGARDING THE PT'S CONDITION. IT WAS REPORTED THAT THE VENTILATOR WAS EXAMINED BY AN ENGINEER FROM THE DISTRIBUTOR. EVAL OF THE UNIT REVEALED NO PROBLEMS WITH THE VENTILATOR. NO TROUBLE RELATED EVENTS WERE RECORDED IN THE DEVICE HISTORY LOG.
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 | UNK |