Brand Name | CADD-PRIZM VIP SYSTEM |
Type of Device | PUMP, INFUSION, PCA |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC. |
1265 grey fox road |
|
st. paul MN 55112 |
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 7935805 |
MDR Text Key | 122721851 |
Report Number | 3012307300-2018-03944 |
Device Sequence Number | 1 |
Product Code |
MEA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
11/14/2018 |
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 |
No Information
|
Device Model Number | 6101 |
Device Catalogue Number | 21-8821-01 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/14/2018 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
09/07/2018 |
Initial Date FDA Received | 10/04/2018 |
Supplement Dates Manufacturer Received | 10/15/2018
|
Supplement Dates FDA Received | 11/14/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/14/2013 |
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 |
|
|