Brand Name | OSCAR 2, 250D |
Type of Device | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE |
Manufacturer (Section D) |
SUNTECH MEDICAL, INC. |
507 airport blvd, suite 117 |
morrisville, nc |
|
Manufacturer (Section G) |
SUNTECH MEDICAL, INC. |
507 airport blvd, suite 117 |
|
morrisville, nc |
|
Manufacturer Contact |
charles
setzer
|
507 airport blvd, suite 117 |
morrisville, nc
|
|
MDR Report Key | 9723832 |
MDR Text Key | 193400089 |
Report Number | 1036863-2020-00002 |
Device Sequence Number | 1 |
Product Code |
DXN
|
Combination Product (y/n) | N |
Reporter Country Code | DR |
PMA/PMN Number | K151500 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
12/02/2019 |
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 |
No Information
|
Device Model Number | 250D |
Device Catalogue Number | 99-0233-40 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/12/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/02/2019 |
Initial Date FDA Received | 02/18/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/27/2019 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Removal/Correction Number | 84531 |
Patient Sequence Number | 1 |
|
|