Brand Name | FLOW-I C30 |
Manufacturer (Section D) |
MAQUET CRITICAL CARE AB |
solna |
SW |
|
Manufacturer (Section G) |
MAQUET CRITICAL CARE AB |
|
|
solna 1715 4 |
SW
17154
|
|
Manufacturer Contact |
janice
pevide
|
45 barbour pond drive |
wayne, NJ 07470
|
9737097753
|
|
MDR Report Key | 4144342 |
MDR Text Key | 20296657 |
Report Number | 8010042-2014-00422 |
Device Sequence Number | 1 |
Product Code |
BSZ
|
Combination Product (y/n) | N |
Reporter Country Code | BE |
PMA/PMN Number | 133958 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
09/23/2014,09/09/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 6677300 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 09/17/2014 |
Device Age | 21 MO |
Event Location |
Hospital
|
Initial Date Manufacturer Received |
09/09/2014
|
Initial Date FDA Received | 09/23/2014 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 12/01/2012 |
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 |
|
|