Brand Name | RAPIDPOINT 500 BLOOD GAS ANALYZER |
Type of Device | RP 500 |
Manufacturer (Section D) |
SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict avenue |
tarrytown NY 10591 |
|
Manufacturer (Section G) |
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD. |
northern road |
chilton industrial estate |
sudbury, CO10 2XQ |
UK
CO10 2XQ
|
|
Manufacturer Contact |
steven
andberg
|
2 edgewater drive |
norwood, MA 02062
|
7812693655
|
|
MDR Report Key | 7638799 |
MDR Text Key | 112576053 |
Report Number | 3002637618-2018-00071 |
Device Sequence Number | 1 |
Product Code |
CHL
|
UDI-Device Identifier | 00630414589169 |
UDI-Public | 00630414589169 |
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 |
Health Professional
|
Type of Report
| Initial |
Report Date |
06/26/2018 |
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 |
Health Professional
|
Device Catalogue Number | 10492730 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/31/2018 |
Initial Date FDA Received | 06/26/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Age | 74 YR |