FDA Adverse Event
Malfunction
Summary report: N
CBK
MDR report key: 2110955
·
Received March 16, 2011
Report
- Report Number
- 8010042-2011-00037
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- December 26, 2010
- Report Date
- March 7, 2011
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K062793
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
THE VENTILATOR GENERATED ALARM FOR A HIGH AIRWAY PRESSURE, HIGH RESPIRATORY RATE AND LOW EXPIRATORY MINUTE VOLUME. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CBK | SERVO-I | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |