Brand Name | BED-CHECK |
Type of Device | BED PATIENT MONITOR |
Manufacturer (Section D) |
STANLEY SECURITY SOLUTIONS, INC. |
4600 vine street |
lincoln NE 68503 |
|
Manufacturer (Section G) |
STANLEY SECURITY SOLUTIONS, INC. |
4600 vine street |
|
lincoln NE 68503 |
|
Manufacturer Contact |
gina
bennett
|
4600 vine street |
lincoln, NE 68503
|
4027429322
|
|
MDR Report Key | 6413106 |
MDR Text Key | 70336819 |
Report Number | 1929691-2017-00009 |
Device Sequence Number | 1 |
Product Code |
KMI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,user facility |
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
12/30/2016 |
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 | 74030 |
Device Catalogue Number | 74030 |
Device Lot Number | N/I |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 12/30/2016 |
Initial Date Manufacturer Received |
02/20/2017
|
Initial Date FDA Received | 03/17/2017 |
Was Device Evaluated by Manufacturer? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 54 YR |
Patient Weight | 49 |
|
|