Brand Name | LUCAS 2 CHEST COMPRESSION SYSTEM |
Type of Device | COMPRESSOR, CARDIAC, EXTERNAL / DRM |
Manufacturer (Section D) |
JOLIFE AB - 3005445717 |
scheelevagen 17 |
ideon science park |
lund SE-22 3 70 |
SW SE-223 70 |
|
Manufacturer (Section G) |
JOLIFE AB - 3005445717 |
scheelevagen 17 |
ideon science park |
lund SE-22 3 70 |
SW
SE-223 70
|
|
Manufacturer Contact |
todd
bandy
|
11811 willows road ne |
redmond, WA 98052
|
4258674000
|
|
MDR Report Key | 15921125 |
MDR Text Key | 304864862 |
Report Number | 0003015876-2022-02650 |
Device Sequence Number | 1 |
Product Code |
DRM
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
11/22/2022,12/05/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | LUCAS |
Device Catalogue Number | 11576-000080 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/05/2022 |
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 11/22/2022 |
Distributor Facility Aware Date | 11/10/2022 |
Device Age | 1 YR |
Event Location |
Other
|
Date Report to Manufacturer | 11/22/2022 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 12/05/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/29/2017 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |