MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-09-07 for OXIMAX SINGLE-PATIENT-USE, ADHESIVE SENSORS MAX-P * manufactured by Covidien Nellcor.
[20351558]
Anesthesia staff report an oximax pediatric oxygen sensor failed to work appropriately. Staff states that it was making a noisy signal before being attached to the patient. Another device was obtained and worked without incident. Device saved by risk management and is available for evaluation purposes. ======================health professional's impression======================it failed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1849168 |
| MDR Report Key | 1849168 |
| Date Received | 2010-09-07 |
| Date of Report | 2010-09-07 |
| Date of Event | 2010-09-02 |
| Report Date | 2010-09-07 |
| Date Reported to FDA | 2010-09-07 |
| Date Added to Maude | 2010-09-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXIMAX SINGLE-PATIENT-USE, ADHESIVE SENSORS |
| Generic Name | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| Product Code | CCL |
| Date Received | 2010-09-07 |
| Model Number | MAX-P |
| Catalog Number | * |
| Lot Number | 0148105 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN NELLCOR |
| Manufacturer Address | 6135 GUNBARREL AVENUE BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-07 |