N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9578618
- MDR report key
- 9578618
- Report number
- 2936999-2020-00045
- Event key
- 0
- Event type
- 3
- Date received
- 2020-01-10
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- 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 | OXIMAX N-595 PULSE OXIMETER | MEDIANA CO. LTD. | PGJ | N595-1 | N595-1 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-01-10 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, THE UNIT'S ALARM SOUNDS POWERED ON BUT DOES NOT WORK PROPERLY. IT WAS STATED THAT ALARM NEVER WORKS. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.