MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-08 for DATEX OHMEDA E-CAIO GAS MODULE E-CAIO-00 manufactured by Ge Healthcare.
[94267697]
Patient Sequence No: 1, Text Type: N, H10
[94267698]
We ordered the co2 absorber to perform preventive maintenance (pm) on the co2 module. The pm procedure states, "the co2 absorber is recommended to be replaced once in four years. " we received 5 co2 absorber about a month ago and 4 of the 5 have an expiration date on them of 4 years from now, but the 5 has an expiration date of about 5 years from now. If the absorber is not to be replaced for 4 years then the parts that are being shipped should have a minimum expiration of 4 years as well. If we go by the recommendation we will have an expired absorber in our co2 module.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7099047 |
| MDR Report Key | 7099047 |
| Date Received | 2017-12-08 |
| Date of Report | 2017-11-10 |
| Date of Event | 2017-11-10 |
| Report Date | 2017-11-10 |
| Date Reported to FDA | 2017-11-10 |
| Date Reported to Mfgr | 2017-11-10 |
| Date Added to Maude | 2017-12-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DATEX OHMEDA E-CAIO GAS MODULE |
| Generic Name | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| Product Code | CCL |
| Date Received | 2017-12-08 |
| Model Number | E-CAIO-00 |
| Device Availability | * |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | 8200 W TOWER AVE MILWAUKEE WI 53223 US 53223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-08 |