Brand Name | NT821731C, EDS 3, GEN LL, NO CATHETER |
Type of Device | NT821731C, EDS 3, GEN LL, NO CATHETER |
Manufacturer (Section D) |
NATUS MEDICAL INCORPORATED |
5955 pacific center boulevard |
san diego |
CA 92121 |
|
Manufacturer (Section G) |
NATUS MANUFACTURING LIMITED |
ida business park |
gort |
h91pd92, |
EI
|
|
Manufacturer Contact |
gráinne
walsh
|
5955 pacific center boulevard |
san diego, CA 92121
|
|
MDR Report Key | 18640374 |
MDR Text Key | 334667254 |
Report Number | 2023988-2024-00012 |
Device Sequence Number | 1 |
Product Code |
JXG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K162437 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
03/06/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/05/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | NT821731C |
Device Catalogue Number | NT821731C |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 01/18/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|