FDA Adverse Event
Summary report: N
FASTRACH
MDR report key: 1613965
·
Received February 2, 2010
Report
- Report Number
- 1613965
- Date Received
- February 2, 2010
- Date of Event
- February 1, 2010
- Report Date
- February 2, 2010
- Manufacturer
- LMA NORTH AMERICA, INC
- Product Code
- BTR
- Report Source
- User Facility report
- Reporter Location
- MA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A PATIENT'S AIRWAY WAS PROTECTED USING A FASTRACH LMA (LARYNGEAL MASK AIRWAY). THE DEVICE IS AN LMA THAT THE ANESTHESIOLOGIST INSERTS THEN SNAKES AN ENDOTRACHEAL TUBE (ETT) OVER TO PROTECT AIRWAY. DEVICE IS MARKETED TO SECURE THE AIRWAY DURING RESCUE AND PRE-HOSPITAL. NOWHERE ON THE PACKAGING DOES IT SAY THAT THE LMA CONTAINS METAL AND IS THEREFORE NOT MRI SAFE. PATIENT WAS TAKEN INTO MRI SCANNER AND SCANNED; HIS WHOLE NECK APPEARED TO BE FULL OF METAL. AIRWAY EXCHANGED TO REGULAR ENDOTRACHEAL TUBE AND SCAN REDONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FASTRACH | INTUBATING LMA (RESCUE AIRWAY DEVICE) | BTR | LMA NORTH AMERICA, INC | REF 136079 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |