Brand Name | YAMATO PLUS-R 7.5FR. 30CC IAB - JAPAN |
Type of Device | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
Manufacturer (Section D) |
DATASCOPE FAIRFIELD |
15 law drive |
fairfield NJ 07004 |
|
Manufacturer (Section G) |
DATASCOPE FAIRFIELD |
15 law drive |
|
fairfield NJ 07004 |
|
Manufacturer Contact |
|
15 law drive |
fairfield, NJ 07004
|
|
MDR Report Key | 7145020 |
MDR Text Key | 95927802 |
Report Number | 2248146-2017-00734 |
Device Sequence Number | 1 |
Product Code |
DSP
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
12/22/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/22/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 04/14/2019 |
Device Catalogue Number | 0684-00-0549-01 |
Device Lot Number | 3000027817 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Device Age | YR |
Date Manufacturer Received | 12/01/2017 |
Date Device Manufactured | 04/14/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 58 YR |
Patient Weight | 48 |