FDA Adverse Event
Other
Summary report: N
GAS MODULE III
MDR report key: 3844658
·
Received May 6, 2014
Report
- Report Number
- 2221819-2014-00172
- Event Type
- Other
- Date Received
- May 6, 2014
- Date of Event
- April 3, 2014
- Report Date
- April 7, 2014
- Manufacturer
- MINDRAY DS USA, INC.
- Product Code
- MHX
- PMA / PMN Number
- 062754
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
COMPANY REPRESENTATIVE EVALUATED THE UNIT. CORRECTIONS INCLUDED REPLACEMENT OF THE PUMP, OXYGEN FILTER TUBING, O2 FILTER, AND CO2 ABSORBER FILTER, AND READJUSTING THE POWER SUPPLY. UNIT WAS CALIBRATED AND SAFETY TESTED TO FACTORY'S SPECIFICATIONS.
Description of Event or Problem · 1
CUSTOMER REPORTED AN ISSUE WITH THE GAS MODULE III,M WHICH MAY HAVE AFFECTED GAS MONITORING. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271387 | GAS MODULE III | GAS MODULE | MHX | MINDRAY DS USA, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |