Brand Name | CARDIOHELP |
Type of Device | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
MAQUET CARDIOPULMONARY GMBH |
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Manufacturer (Section G) |
JULIA KAPFENBERGER |
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Manufacturer Contact |
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MDR Report Key | 18987267 |
MDR Text Key | 338720078 |
Report Number | 8010762-2024-00165 |
Device Sequence Number | 1 |
Product Code |
DTQ
|
Combination Product (y/n) | N |
Reporter Country Code | PO |
PMA/PMN Number | K133598 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/27/2024 |
1 Device was Involved in the Event |
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1 Patient was Involved in the Event |
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Date FDA Received | 03/27/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | CARDIOHELP-I |
Device Catalogue Number | 701048012 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/25/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/03/2017 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
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