FDA Adverse Event
Malfunction
Summary report: N
SERVO-I
MDR report key: 3110528
·
Received April 8, 2013
Report
- Report Number
- 8010042-2013-00043
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K062793
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE VENTILATOR TIPPED FORWARD BY ITSELF BECAUSE THE SCREW THAT ATTACHES THE VENTILATOR TO THE CART HAD NOT BEEN ATTACHED PROPERLY. THE SERVICE TECHNICIAN CAUGHT THE VENTILATOR AS IT FELL, NO ONE WAS HARMED. THE TECHNICIAN REPLACED PARTS AND PERFORMED FUNCTIONAL CHECKOUT, PRE-USE TEST, AND ELECTRICAL SAFETY CHECK. THE UNIT PASSED ALL TESTS. NO SIMILAR EVENTS WERE FOUND IN THE COMPLAINT DATABASE. THE INCIDENT HAS BEEN REPORTED TO PRODUCTION FOR THEIR INVESTIGATION. (B)(4).
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144326 | SERVO-I | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |