FDA Adverse Event
Malfunction
Summary report: N
SERVO-I
MDR report key: 4090098
·
Received August 18, 2014
Report
- Report Number
- 8010042-2014-00356
- Event Type
- Malfunction
- Date Received
- August 18, 2014
- Date of Event
- August 2, 2014
- Report Date
- August 4, 2014
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K123149
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
MORE INFORMATION SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED WHEN INVESTIGATION IS FINISHED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PATIENT, IT GENERATED ALARM FOR HIGH OXYGEN CONCENTRATION. THERE WAS NO PATIENT HARM. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 496257 | SERVO-I | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |