Brand Name | FLOW METER |
Type of Device | FLOWMETER, NONBACK-PRESSURE COMPENSATED, BOURDON GAUGE |
Manufacturer (Section D) |
OHIO MEDICAL LLC |
1111 lakeside dr |
gurnee IL 60031 |
|
MDR Report Key | 9769331 |
MDR Text Key | 181363006 |
Report Number | 9769331 |
Device Sequence Number | 1 |
Product Code |
CCN
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
02/24/2020,02/14/2020 |
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 |
Other
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 02/24/2020 |
Event Location |
Hospital
|
Date Report to Manufacturer | 02/28/2020 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 02/28/2020 |
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|