Brand Name | HLS CANNULAE & PIK |
Type of Device | CATHETER, CANNULA AND TUBING, VASCULAR, 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 | 19180867 |
MDR Text Key | 341028448 |
Report Number | 8010762-2024-00229 |
Device Sequence Number | 1 |
Product Code |
DWF
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K102532 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/25/2024 |
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
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | UNKNOWN |
Device Catalogue Number | UNKNOWN |
Device Lot Number | UNKNOWN |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/04/2024
|
Initial Date FDA Received | 04/25/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
A
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
|