MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-01-12 for GAS MODULE III manufactured by Mindray Bio-medical Electronics Co, Ltd.
[5569489]
Customer reported an issue with the gas module iii, which may have affected gas monitoring. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[12910011]
Company representative evaluated the unit and verified the problem. Corrections included replacement of the unit's fan, oxygen filter tubing, tubing to the water trap, and adjusting the power supply. Unit was calibrated and safety tested to factory's specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2221819-2014-01061 |
| MDR Report Key | 4479794 |
| Report Source | 05,06,07 |
| Date Received | 2015-01-12 |
| Date of Report | 2014-11-13 |
| Date of Event | 2014-11-05 |
| Date Facility Aware | 2014-11-13 |
| Report Date | 2014-12-10 |
| Date Mfgr Received | 2014-11-13 |
| Date Added to Maude | 2015-03-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | WISARA SETHACHUTKUL |
| Manufacturer Street | 800 MACARTHUR BLVD. |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2019958045 |
| Manufacturer G1 | MINDRAY BIO-MEDICAL ELECTRONICS CO, LTD |
| Manufacturer Street | KEJI 12TH ROAD SOUTH HT INDUSTRIAL PARK |
| Manufacturer City | NANSHAN, SHENZHEN 518057 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 518057 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAS MODULE III |
| Generic Name | GAS MODULE |
| Product Code | BZK |
| Date Received | 2015-01-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MINDRAY BIO-MEDICAL ELECTRONICS CO, LTD |
| Manufacturer Address | SHENZHEN CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-12 |