MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-03-26 for LUCAS ? CPR CHEST COMPRESSION SYSTEM 99576-000026 manufactured by Jolife Ab - 3005445717.
[186565649]
Physio-control performed an clinical review and determined that based on the available information, the device use may have contributed to the patient outcome. It can not be excluded that the liver lacerations occur when providing chest compressions during both manual and mechanical cpr. Rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186565650]
The customer contacted physio-control to report that their device had potentially caused liver laceration, a broken rib, and refractory bleeding, during patient use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0003015876-2020-00438 |
| MDR Report Key | 9884845 |
| Report Source | FOREIGN |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-01 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2017-03-03 |
| Date Added to Maude | 2020-03-26 |
| 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 | 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 | 2020-03-26 |
| Model Number | LUCAS |
| Catalog Number | 99576-000026 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-03-26 |