Brand Name | ENDOPHYS PSAS SYSTEM |
Type of Device | COMPUTER, BLOOD PRESSURE - ENDOPHYS BLOOD PRESSURE MONITOR |
Manufacturer (Section D) |
|
MDR Report Key | 8807315 |
MDR Text Key | 151700466 |
Report Number | MW5088229 |
Device Sequence Number | 1 |
Product Code |
DSK
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
07/16/2019 |
2 Devices were Involved in the Event: |
1
2
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | BPM-20-SC |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/08/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 07/18/2019 |
Was Device Evaluated by Manufacturer? |
No Information
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 165 YR |
|
|