N
Patient 1
MAUDE MDR 6135884
- MDR report key
- 6135884
- Report number
- 6135884
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-09-08
- Date received
- 2016-11-30
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 401
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ANESTHESIA BREATHING CIRCUIT KIT | ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC) | WESTMED, INC. | OFP | 9313 | * | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-11-30 | 0 |
Event Narratives#
D
Patient 1
DURING SURGERY, ANESTHESIOLOGIST SUSPECTED PATIENT WAS NOT RESPONDING TO ANESTHETIC AGENT, SEVOFLURANE. CASE WAS JUST GETTING STARTED. AT FIRST IT WAS THOUGHT THAT THE PROBLEM WAS WITH THE ANESTHESIA VENTILATOR, BUT MD REQUESTED SWITCHING OUT THE PATIENT'S BREATHING CIRCUIT. PROBLEM WAS RESOLVED.