Brand Name | RAPIDPOINT 500 |
Type of Device | RP 500 |
Manufacturer (Section D) |
SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict avenue |
tarrytown 10591 |
|
Manufacturer (Section G) |
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD. |
northern road |
chilton industry |
sudbury CO10 2XQ |
UK
CO10 2XQ
|
|
Manufacturer Contact |
steven
andberg
|
2 edgewater drive |
norwood, MA 02062
|
7812693655
|
|
MDR Report Key | 5267439 |
MDR Text Key | 32901763 |
Report Number | 1217157-2015-00179 |
Device Sequence Number | 1 |
Product Code |
KQO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K113216 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/04/2015 |
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 Health Care Professional
|
Device Catalogue Number | 10492730 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/11/2015 |
Initial Date FDA Received | 12/04/2015 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |