| Brand Name | NEPTUNE 2 DOCKING STATION (120V) |
|---|
| Type of Device | APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED |
|---|
| Manufacturer (Section D) |
| STRYKER INSTRUMENTS-KALAMAZOO |
| 4100 east milham avenue |
| kalamazoo MI 49001 |
|
|---|
| Manufacturer (Section G) |
| STRYKER INSTRUMENTS-KALAMAZOO |
| 4100 east milham avenue |
|
| kalamazoo MI 49001 |
|
|---|
| Manufacturer Contact |
|
zach
baker
|
| 4100 east milham avenue |
| kalamazoo, MI 49001
|
|
2693237700
|
|
|---|
| MDR Report Key | 9251722 |
|---|
| MDR Text Key | 164160897 |
|---|
| Report Number | 0001811755-2019-03555 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code |
JCX
|
| UDI-Device Identifier | 07613154559053 |
|---|
| UDI-Public | 07613154559053 |
|---|
| Combination Product (y/n) | N |
|---|
| Reporter Country Code | US |
|---|
| Number of Events Reported | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Report Source |
Manufacturer
|
|---|
| Source Type |
user facility |
|---|
| Reporter Occupation |
Biomedical Engineer
|
|---|
| Type of Report
| Initial |
|---|
| Report Date |
10/29/2019 |
|---|
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Date FDA Received | 10/29/2019 |
|---|
| Is this an Adverse Event Report? |
No
|
|---|
| Is this a Product Problem Report? |
Yes
|
|---|
| Device Operator |
No Information
|
|---|
| Device Catalogue Number | 0702014000 |
|---|
| Was Device Available for Evaluation? |
Yes
|
|---|
| Is the Reporter a Health Professional? |
Yes
|
|---|
| Date Manufacturer Received | 10/02/2019 |
|---|
| Was Device Evaluated by Manufacturer? |
Yes
|
|---|
| Date Device Manufactured | 07/31/2017 |
|---|
| Is the Device Single Use? |
No
|
|---|
| Is This a Reprocessed and Reused Single-Use Device? |
No
|
|---|
| Type of Device Usage |
Reuse
|
|---|
| Patient Sequence Number | 1 |
|---|
|
|
