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.
[18037997]
Customer reported an issue with the gas module iii, which may have affected o2 monitoring. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[18119934]
Company representative evaluated the unit. Corrections included replacement of the unit's bench assembly and calibration. Unit was safety tested to factory's specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2221819-2014-01105 |
| MDR Report Key | 4479825 |
| Report Source | 05,06,07 |
| Date Received | 2015-01-12 |
| Date of Report | 2014-11-21 |
| Date of Event | 2014-11-21 |
| Date Facility Aware | 2014-11-21 |
| Report Date | 2014-11-21 |
| Date Mfgr Received | 2014-11-21 |
| Date Added to Maude | 2015-03-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 |
| 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 | NANSHAN, SHENZHEN CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-12 |