N
Patient 1
MAUDE MDR 7178130
- MDR report key
- 7178130
- Report number
- 7178130
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-12-14
- Date received
- 2018-01-10
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- 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 | SODASORB | ABSORBENT, CARBON-DIOXIDE | SMITHS MEDICAL ASD, INC. | CBL | 008870 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-01-10 | 0 |
Event Narratives#
D
Patient 1
THE DESIGN OF THE PRODUCT ALLOWS FOR THE PRODUCT TO BE PLACED IN THE ANESTHESIA MACHINE (MINDRAY) UPSIDE DOWN AND ONCE THE ABSORBENT IS EXHAUSTED AND WET THE CANISTER CANNOT BE RELEASED FROM THE HOLDER. THE UPPER CIRCUMFERENCE OF THE CANISTER IS MARGINALLY LARGER THAN THE BOTTOM; HOWEVER THERE IS NO NOTATION ON THE SUPPLY TO INDICATE HOW THE CANISTER SHOULD BE PLACED IN THE HOLDER I.E. THIS END UP, ETC. ONE PATIENT'S ETC02 REACHED 70 AND REQUIRED MANUAL VENTILATION WHILE THE CANISTER WAS REMOVED FROM THE HOLDER.