MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-06 for OXYGEN SENSOR 10097559 manufactured by Covidien.
[72127832]
Patient Sequence No: 1, Text Type: N, H10
[72127833]
It was reported that the voltage on oxygen (o2) sensor fluctuates. The device was not in use on a patient at the time the malfunction occurred. The service engineer (se) verified the malfunction and replaced the o2 sensor. The unit passed all testing and operates within the manufacturing specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020893-2017-05574 |
| MDR Report Key | 6463230 |
| Date Received | 2017-04-06 |
| Date of Report | 2017-03-12 |
| Date of Event | 2017-03-12 |
| Date Mfgr Received | 2017-03-12 |
| Date Added to Maude | 2017-04-06 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | RAY MAROOFIAN |
| Manufacturer Street | 2101 FARADAY AVE. |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7606035334 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | MICHEAL COLLINS RD MERVUE |
| Manufacturer City | GALWAY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OXYGEN SENSOR |
| Generic Name | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| Product Code | CCL |
| Date Received | 2017-04-06 |
| Model Number | OXYGEN SENSOR |
| Catalog Number | 10097559 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | MICHEAL COLLINS RD MERVUE GALWAY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-06 |