FDA Adverse Event
Injury
Summary report: N
GALILEO VENTILATOR
MDR report key: 516102
·
Received March 2, 2004
Report
- Report Number
- MW1031408
- Event Type
- Injury
- Date Received
- March 2, 2004
- Date of Event
- January 31, 2004
- Report Date
- March 2, 2004
- Manufacturer
- HAMILTON MEDICAL, INC.
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- RI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
TECHNICAL ERROR NOTED IN THE VENTILATOR. VENTILATOR CHANGED. NO ILL EFFECTS TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GALILEO VENTILATOR | VENTILATOR | CBK | HAMILTON MEDICAL, INC. | 98/155021 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |