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, 92121 CA |
|
MDR Report Key | 12076342 |
MDR Text Key | 265584270 |
Report Number | 2023988-2021-00014 |
Device Sequence Number | 1 |
Product Code |
JXG
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Type of Report
| Initial,Followup,Followup |
Report Date |
08/26/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/28/2021 |
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? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/18/2021 |
Date Manufacturer Received | 06/09/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 34 YR |
|
|