D
Patient 1
CUSTOMER REPORTED AN ISSUE WITH THE GAS MODULE II, WHICH MAY HAVE AFFECTED GAS MONITORING. NO PATIENT INJURY WAS REPORTED.
MAUDE MDR 4037834
- MDR report key
- 4037834
- Report number
- 2221819-2014-00435
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-06-19
- Date received
- 2014-08-21
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- WISARA SETHACHUTKUL
- Address
- 800 MACARTHUR BLVD. MAHWAH NJ 07430 US
- Phone
- 201-201-2019
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GAS MODULE II | GAS MODULE | MINDRAY DS USA INC | BZK | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-08-21 | 0 |
Event Narratives#
N
Patient 1
CO REP EVALUATED THE UNIT. CORRECTIONS INCLUDED REPLACEMENT OF THE UNIT'S PUMP. UNIT WAS CALIBRATED AND SAFETY TESTED TO FACTORY'S SPECIFICATIONS.