FDA Adverse Event
Malfunction
Summary report: N
SERVO-1
MDR report key: 3862183
·
Received April 24, 2014
Report
- Report Number
- 8010042-2014-00183
- Event Type
- Malfunction
- Date Received
- April 24, 2014
- Date of Event
- March 29, 2014
- Report Date
- March 29, 2014
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K062793
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER HAS BEEN ON SITE AND STARTED THE INVESTIGATION. THE AIR GAS MODULE WAS FOUND DEFECTIVE AND HAS BEEN REPLACED. THE REPLACED PART HAS BEEN REQUESTED BUT NOT YET RECEIVED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTILATOR SHOWED EXCESSIVE LEAKAGE DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 248265 | SERVO-1 | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |