Brand Name | SKYTRON |
Type of Device | SKYBOOM |
Manufacturer (Section D) |
|
Manufacturer (Section G) |
SKYTRON, DIV. THE KMW GROUP, INC. |
5000 36th st., s.e. |
|
grand rapids MI 49512 |
|
Manufacturer Contact |
|
5000 36th st., s.e. |
grand rapids, MI 49512
|
|
MDR Report Key | 5197088 |
MDR Text Key | 30331168 |
Report Number | 1825014-2015-00047 |
Device Sequence Number | 1 |
Product Code |
FTA
|
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Type of Report
| Initial |
Report Date |
10/20/2015 |
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 Model Number | 110 SERIES |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 10/20/2015 |
Distributor Facility Aware Date | 10/16/2015 |
Device Age | 1 MO |
Event Location |
Hospital
|
Date Report to Manufacturer | 10/21/2015 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 10/20/2015 |
Was Device Evaluated by Manufacturer? |
No Information
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|