N
Patient 1
(B)(4). AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION.
MAUDE MDR 7724481
- MDR report key
- 7724481
- Report number
- 8030673-2018-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-06-04
- Date received
- 2018-07-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MINDY FABER
- Address
- 26125 NORTH RIVERWOODS BLVD METTAWA IL 60045 US
- Phone
- 872-872-8727
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PED, 40" TUBE RESVR, PED MASK | PED, 40" TUBE RESVR, PED MASK, MANO, P/O VALVE, 10' O2 TBG | VYAIRE MEDICAL | OEV | 2K8008 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-07-26 | 0 |
Event Narratives#
D
Patient 1
CUSTOMER REPORTED: CHILD HAD NEURO EVENT WHERE HE/SHE FORGOT TO BREATH. ON 5 LITER OF O2 ON TANK AND INCREASED TO 8 LITERS. NURSE WAS ALERTED TO THIS ISSUE WHEN SHE NOTICED THERE WAS NO AIRFLOW THROUGH BAG. NURSE REPORTED THERE WAS NO PATIENT HARM OR INJURY.