FDA Adverse Event
Malfunction
Summary report: N
SERVO VENTILATOR 300
MDR report key: 1942686
·
Received December 1, 2010
Report
- Report Number
- 8010042-2010-00275
- Event Type
- Malfunction
- Date Received
- December 1, 2010
- Date of Event
- October 4, 2010
- Report Date
- October 8, 2010
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K970839
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER PERFORMING THE 3000H MAINTENANCE ON THE VENTILATOR ON (B)(6), 2010 THE RESPIRATORY THERAPIST TURNED OFF THE VENTILATOR. DURING THE NIGHT THE RESPIRATORY THERAPIST TEAM LEADER SMELT A SCORCHING SMELL. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERVO VENTILATOR 300 | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |