Brand Name | SURELIFE ARM BP MONITOR-PREMIUM |
Type of Device | SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE |
Manufacturer (Section D) |
MHC MEDICAL PRODUCTS, LLC |
11930 kemper springs drive |
cincinnati OH 45240 |
|
Manufacturer (Section G) |
MHC MEDICAL PRODUCTS, LLC. |
11930 kemper springs drive |
|
cincinnati OH 45240 |
|
Manufacturer Contact |
jennifer
seiple
|
11930 kemper springs drive |
cincinnati, OH 45240
|
|
MDR Report Key | 7632186 |
MDR Text Key | 112165411 |
Report Number | 3005798905-2018-02138 |
Device Sequence Number | 1 |
Product Code |
DXN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K091434 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Patient
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
06/22/2018 |
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 |
Lay User/Patient
|
Device Catalogue Number | 860214 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/07/2017 |
Initial Date FDA Received | 06/22/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|