MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2014-12-16 for CHECK O2 PLUS OXYGEN ANALYZER 9153653302 IRC450 manufactured by Maxtec Inc..
[5222206]
Dealer states unit is not reading anything. Display is on but unit is not functioning. Dealer spoke with tech and was advised to replace unit under warranty. Original order (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2014-06341 |
| MDR Report Key | 4333401 |
| Report Source | * |
| Date Received | 2014-12-16 |
| Date of Report | 2014-11-21 |
| Date Facility Aware | 2014-11-21 |
| Report Date | 2014-12-15 |
| Date Reported to FDA | 2014-12-15 |
| Date Reported to Mfgr | 2014-12-15 |
| Date Added to Maude | 2014-12-16 |
| 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 | 2014-12-16 |
| Model Number | IRC450 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 29 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 | 2014-12-16 |