Brand Name | ACQMAP HIGH RESOLUTION IMAGING + MAPPING SYSTEM |
Type of Device | PROGRAMMABLE DIAGNOSTIC COMPUTER |
Manufacturer (Section D) |
ACUTUS MEDICAL, INC. |
2210 faraday avenue |
suite 100 |
carlsbad CA 92008 |
|
Manufacturer (Section G) |
ACUTUS MEDICAL, INC. |
2210 faraday avenue |
suite 100 |
carlsbad CA 92008 |
|
Manufacturer Contact |
karen
kincade
|
2210 faraday avenue |
suite 100 |
carlsbad, CA 92008
|
4422326123
|
|
MDR Report Key | 10623443 |
MDR Text Key | 213428433 |
Report Number | 3012120746-2020-00005 |
Device Sequence Number | 1 |
Product Code |
DQK
|
UDI-Device Identifier | 00857042007296 |
UDI-Public | (01)00857042007296(11)200520 |
Combination Product (y/n) | N |
Reporter Country Code | SW |
PMA/PMN Number | K190131 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
10/02/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 800500 |
Device Catalogue Number | 800500 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/07/2020 |
Initial Date FDA Received | 10/02/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/20/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Life Threatening;
Required Intervention;
|
Patient Age | 67 YR |