Brand Name | OMRON BLOOD PRESSURE MONITOR, BP786N |
Type of Device | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE |
Manufacturer (Section D) |
|
MDR Report Key | 9123900 |
MDR Text Key | 160304800 |
Report Number | MW5090040 |
Device Sequence Number | 1 |
Product Code |
DXN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
09/24/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/25/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | BP786N |
Device Catalogue Number | HEM-7321T-Z(V) |
Was Device Available for Evaluation? |
Yes
|
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 62 YR |
Patient Weight | 99 |
|
|