MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-14 for AMBU BLUESENSOR R R-00-S/25 manufactured by Ambu A/s.
| Report Number | 1220828-2019-00011 |
| MDR Report Key | 9186656 |
| Date Received | 2019-10-14 |
| Date of Report | 2019-10-14 |
| Date of Event | 2019-08-31 |
| Date Facility Aware | 2019-10-11 |
| Date Added to Maude | 2019-10-14 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | AMBU BLUESENSOR R |
| Generic Name | ELECTROCARDIOGRAPHIC ELECTRODE, SINGLE-USE, PRODUCT CODE: DRX |
| Product Code | DRX |
| Date Received | 2019-10-14 |
| Catalog Number | R-00-S/25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMBU A/S |
| Manufacturer Address | BALTORPBAKKEN 13 BALLERUP, DK 2750 DA 2750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-14 |