N
Patient 1
INITIAL MDR SUBMISSION. TO DATE NO SAMPLE HAS BEEN PROVIDED FROM THE CUSTOMER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP SUBMISSION WILL BE FILED. (B)(4).
MAUDE MDR 6830010
- MDR report key
- 6830010
- Report number
- 3010838917-2017-00036
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-07-24
- Date received
- 2017-08-30
- 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
- MINDY FABER
- Address
- 26125 NORTH RIVERWOODS BLVD. METTAWA IL 60045 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CABLE, IBP, SINGLE, ARGON, 3.6 M | DISPLAY, CATHODE-RAY TUBE, MEDICAL | VYAIRE MEDICAL, INC | DXJ | 2016995-001 | 201503K | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-08-30 | 0 | 1. R |
Event Narratives#
D
Patient 1
THE PATIENT WAS IN ICU AND HAS A SERIOUS ARDS (?) AND HE/SHE WAS TURNED TO THE PRONE POSITION. SOON AFTER THAT INVBP VALUES WERE VERY HIGH. BECAUSE OF THAT NORADRENALIN INFUSION WAS STOPPED AND FENTANYL AND PROPOFOL WAS STARTED. WHEN NORADRENALIN WAS STOPPED THE INVBP CURVE HAD DISAPPEARED SUDDENLY. BECAUSE THE NEXT BP VALUE (ALSO NIBP MEASURING WAS STARTED) WAS 40/20. NORADRENALIN INFUSION WAS STARTED AGAIN. THEN A TRUNK CABLE WAS CHANGED TO A NEW ONE AND VALUES BECAME NORMAL AND THE BP CURVE WAS RELIABLE. NO PATIENT INJURY HAS BEEN REPORTED.