Brand Name | SENSICA UO MONITOR ICU |
Type of Device | SENSICA UO MONITORICU |
Manufacturer (Section D) |
ADAPTEC MEDICAL DEVICES LLC 3014271001 |
260 james jackson avenue |
cary NC 27513 |
|
Manufacturer (Section G) |
ADAPTEC MEDICAL DEVICES LLC 3014271001 |
260 james jackson avenue |
|
cary NC 27513 |
|
Manufacturer Contact |
yonic
anderson
|
8195 industrial blvd |
covington, GA 30014
|
7707846100
|
|
MDR Report Key | 11596227 |
MDR Text Key | 243359113 |
Report Number | 1018233-2021-80027 |
Device Sequence Number | 1 |
Product Code |
EXS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,other,use |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/31/2021 |
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 Catalogue Number | SCCS1001 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/14/2020 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/12/2021
|
Initial Date FDA Received | 03/31/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/01/2019 |
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 |