FDA Adverse Event
Malfunction
Summary report: N
SERVO VENTILATOR 300
MDR report key: 869284
·
Received June 21, 2007
Report
- Report Number
- 8010042-2007-00137
- Event Type
- Malfunction
- Date Received
- June 21, 2007
- Date of Event
- April 10, 2007
- Report Date
- June 11, 2007
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K970839
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER PROVIDED FAILURE AND PURCHASING HISTORY DURING A MEETING WITH MAQUET ON JUNE 11, 2007. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY MAQUET CRITICAL CARE. MAQUET CRITICAL CARE PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.
Description of Event or Problem · 1
THE HOSPITAL EXPERIENCED A VENTILATOR PROBLEM RELATED TO A GAS MODULE MALFUNCTION. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERVO VENTILATOR 300 | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |