Brand Name | LUCAS 3, 3.0, IN SHIPPING BOX, EN |
Type of Device | COMPRESSOR, CARDIAC, EXTERNAL |
Manufacturer (Section D) |
JOLIFE AB - 3005445717 |
scheelevagen 17 |
ideon science park |
lund SE-22 3 70 |
SW SE-223 70 |
|
Manufacturer (Section G) |
PHYSIO-CONTROL, INC. - 3015876 |
11811 willows road ne |
ideon science park |
redmond WA 98052 |
|
Manufacturer Contact |
brian
blakeslee
|
11811 willows road ne |
redmond, WA 98052
|
4258674000
|
|
MDR Report Key | 18335220 |
MDR Text Key | 330602654 |
Report Number | 0003015876-2023-02374 |
Device Sequence Number | 1 |
Product Code |
DRM
|
UDI-Device Identifier | 00883873861820 |
UDI-Public | 00883873861820 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K161768 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Source Type |
User Facility |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
12/12/2023,05/08/2024 |
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 3 |
Device Catalogue Number | 99576-000043 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 12/12/2023 |
Device Age | 0 MO |
Event Location |
Other
|
Date Report to Manufacturer | 12/12/2023 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 12/15/2023 |
Supplement Dates Manufacturer Received | 04/22/2024
|
Supplement Dates FDA Received | 05/08/2024
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Treatment | BATTERY,LUCAS,DARK GRAY. |
|
|