Brand Name | OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR |
Type of Device | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE |
Manufacturer (Section D) |
OMRON HEALTHCARE, INC. |
1925 west field court, suite' 100 |
lake forest IL 60045 |
|
MDR Report Key | 11705871 |
MDR Text Key | 246683429 |
Report Number | 11705871 |
Device Sequence Number | 1 |
Product Code |
DXN
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/20/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/22/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | BP7100 |
Device Catalogue Number | BP7100 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 04/20/2021 |
Event Location |
Hospital
|
Date Report to Manufacturer | 04/22/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|