MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2014-12-12 for CHECK O2 PLUS OXYGEN ANALYZER 9153653302 IRC450 manufactured by Maxtec Inc..
[5129335]
The dealer states that he's getting a e07 error which is outside of operating temperature before use. He is in a 72 degree temp when trying to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2014-06189 |
| MDR Report Key | 4324377 |
| Report Source | * |
| Date Received | 2014-12-12 |
| Date of Report | 2014-11-18 |
| Date Facility Aware | 2014-11-18 |
| Report Date | 2014-12-11 |
| Date Reported to FDA | 2014-12-11 |
| Date Reported to Mfgr | 2014-12-11 |
| Date Added to Maude | 2014-12-12 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHECK O2 PLUS OXYGEN ANALYZER 9153653302 |
| Generic Name | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| Product Code | CCL |
| Date Received | 2014-12-12 |
| Model Number | IRC450 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAXTEC INC. |
| Manufacturer Address | 6526 SOUTH COTTONWOOD ST SALT LAKE CITY UT 84107 US 84107 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-12 |