Brand Name | POSEY CHAIR BELT SENSOR |
Manufacturer (Section D) |
J. T. POSEY CO. |
arcadia CA |
|
Manufacturer (Section G) |
DONGGUAN POSEY MEDICAL DEVICE CO., LTD. |
fumin road, tangli village |
fenggang town |
donguan/guangdong |
CH
|
|
Manufacturer Contact |
roxana
koussa
|
5635 peck rd. |
arcadia, CA 91006
|
6264433143
|
|
MDR Report Key | 4174195 |
MDR Text Key | 5156116 |
Report Number | 2020362-2014-00259 |
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 |
User Facility |
Reporter Occupation |
Unknown
|
Type of Report
| Initial |
Report Date |
07/17/2014 |
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 Model Number | 8360 |
Device Catalogue Number | 8360 |
Device Lot Number | 3168D10 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 07/14/2014 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/17/2014
|
Initial Date FDA Received | 08/11/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/01/2013 |
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 |
Treatment | SITTER ELITE: PART #8345, LOT UNK |
|
|