FDA Adverse Event
Malfunction
Summary report: N
SERVO-S
MDR report key: 2223428
·
Received May 20, 2011
Report
- Report Number
- 8010042-2011-00083
- Event Type
- Malfunction
- Date Received
- May 20, 2011
- Date of Event
- May 7, 2011
- Report Date
- May 9, 2011
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K041223
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTILATOR FAILED THE INTERNAL LEAKAGE TEST, THE PRESSURE TRANSDUCER TEST, THE SAFETY VALVE TEST AND THE FLOW TRANSDUCER TEST DURING PRE-USE CHECK. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERVO-S | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |