N
Patient 1
THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9908666
- MDR report key
- 9908666
- Report number
- 8040459-2020-00023
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-12
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- AVI KLUGER
- Address
- 5920 LONGBOW DRIVE BOULDER CO 80301 US
- Phone
- 303-303-3035
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CURITY | TUBE, TRACHEAL (W/WO CONNECTOR) | KENDALL GAMMATRON, THAILAND | BTR | 9570E | 9570E | 1918209FED | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, THE DEVICE WAS USED ON INTUBATION BUT THE VENTILATOR SHOWED NO TIDAL VOLUME. THE DEVICE WAS REPLACED IMMEDIATELY AND FOUND TO HAVE LEAKED.