MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-18 for NIMBUS 3 152010DAR manufactured by Arjohuntleigh Polska Sp Z O.o.
| Report Number | 1419652-2019-00195 |
| MDR Report Key | 9080645 |
| Date Received | 2019-09-18 |
| Date of Report | 2019-09-18 |
| Date of Event | 2018-07-21 |
| Date Facility Aware | 2019-09-09 |
| Report Date | 2019-09-18 |
| Date Reported to FDA | 2019-09-18 |
| Date Reported to Mfgr | 2019-09-18 |
| Date Added to Maude | 2019-09-18 |
| 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 | 3 |
| Brand Name | NIMBUS 3 |
| Generic Name | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE |
| Product Code | FNM |
| Date Received | 2019-09-18 |
| Model Number | 152010DAR |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 7 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP Z O.O |
| Manufacturer Address | KS. WAWRZYNIAKA 2 KOMORNIKI, 62-052 PL 62-052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-09-18 |