Brand Name | RAPIDPOINT 500 BLOOD GAS ANALYZER |
Type of Device | RP 500 |
Manufacturer (Section D) |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
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 |
thomas
myers
|
511 benedict avenue |
tarrytown, NY 10591
|
|
MDR Report Key | 15987928 |
MDR Text Key | 308073995 |
Report Number | 3002637618-2022-00074 |
Device Sequence Number | 1 |
Product Code |
CHL
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K122539 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
02/15/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/15/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 11416755 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/13/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|