FDA Adverse Event
Malfunction
Summary report: N
SERVO-I
MDR report key: 3811005
·
Received March 23, 2014
Report
- Report Number
- 8010042-2014-00098
- Event Type
- Malfunction
- Date Received
- March 23, 2014
- Date of Event
- March 3, 2014
- Report Date
- March 5, 2014
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K062793
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A SERVICE ENGINEER HAS BEEN ON SITE AND STARTED THE INVESTIGATION. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTILATOR FAILED THE PRE-USE CHECK, DISPLAYING AN EXCESSIVE LEAKAGE MESSAGE. THERE WAS NO PT INVOLVEMENT. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171258 | SERVO-I | CBK | MAQUET CRITICAL CARE AB | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |