FDA Adverse Event
Malfunction
Summary report: N
SERVO-I
MDR report key: 1872878
·
Received October 1, 2010
Report
- Report Number
- 8010042-2010-00199
- Event Type
- Malfunction
- Date Received
- October 1, 2010
- Date of Event
- July 9, 2010
- Report Date
- September 7, 2010
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K062793
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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 GAS SUPPLY TEST DURING PRE-USE CHECK, AND THAT A TECHNICAL ERROR CODE WAS GENERATED INDICATING A FAILURE OF THE CONTROL PRINTED CIRCUIT BOARD DURING START UP. (B)(4). MANUFACTURER REF #: 1037MCC0511.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERVO-I | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |