Brand Name | HEART LUNG MACHINE |
Type of Device | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE |
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 | 15273232 |
MDR Text Key | 303144771 |
Report Number | 8010762-2022-00331 |
Device Sequence Number | 1 |
Product Code |
KFM
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K991864 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
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Source Type |
Other,Foreign,Consumer,Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
09/29/2022 |
1 Device was Involved in the Event |
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1 Patient was Involved in the Event |
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Is this an Adverse Event Report? |
Yes
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Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | RFD 20-973 ROTA FLOW DRIVE |
Device Catalogue Number | 701041378 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/08/2022 |
Initial Date FDA Received | 08/23/2022 |
Supplement Dates Manufacturer Received | 09/02/2022
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Supplement Dates FDA Received | 09/29/2022
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Was Device Evaluated by Manufacturer? |
Yes
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Date Device Manufactured | 10/06/2009 |
Is the Device Single Use? |
No
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Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
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