N
Patient 1
MAUDE MDR 7340829
- MDR report key
- 7340829
- Report number
- 7340829
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-03-05
- Date received
- 2018-03-15
- 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 | VITAL SIGNS | ANESTHESIA BREATHING CIRCUIT KIT | VYAIRE MEDICAL, INC. | BSJ | A4G12XXX | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-03-15 | 0 |
Event Narratives#
D
Patient 1
AFTER INTUBATION OF PATIENT, IT WAS FOUND THAT THE END TIDAL CARBON DIOXIDE (CO2) WAS NOT CAPTURING ON THE ANESTHESIA MACHINE. THE DOCTOR STATED NO RECORDING ON THE MONITOR. THE BREATHING CIRCUIT WAS CHECKED AND IT WAS FOUND THAT THE CURVED CONNECTOR ON THE BREATHING MASK DID NOT HAVE A HOLE. THE PIECE WAS SWITCHED AND REPLACED WITH A NEW CONNECTOR AND THE ANESTHESIA MONITOR BEGAN READING THE END TIDAL CO2. RN NOTIFIED THE CHARGE NURSE.