MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-27 for LUCAS ? CPR CHEST COMPRESSION SYSTEM 99576-000026 manufactured by Jolife Ab - 3005445717.
| Report Number | 3005445717-2020-00004 |
| MDR Report Key | 9888854 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-01 |
| Date Facility Aware | 2020-03-03 |
| Report Date | 2020-03-03 |
| Date Reported to Mfgr | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2017-03-03 |
| Date Added to Maude | 2020-03-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TODD BANDY |
| Manufacturer Street | 11811 WILLOWS ROAD NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4258674000 |
| Manufacturer G1 | JOLIFE AB - 3005445717 |
| Manufacturer Street | SCHEELEVAGEN 17 IDEON SCIENCE PARK |
| Manufacturer City | LUND SE-223 70 |
| Manufacturer Country | SE |
| Manufacturer Postal Code | SE-223 70 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUCAS ? CPR CHEST COMPRESSION SYSTEM |
| Generic Name | COMPRESSOR, CARDIAC, EXTERNAL |
| Product Code | DRM |
| Date Received | 2020-03-27 |
| Model Number | LUCAS |
| Catalog Number | 99576-000026 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOLIFE AB - 3005445717 |
| Manufacturer Address | SCHEELEVAGEN 17 IDEON SCIENCE PARK LUND SE-223 70 SE SE-223 70 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-27 |