Brand Name | BIONAIRE |
Type of Device | HUMIDIFIER |
Manufacturer (Section D) |
SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTIONS |
2381 executive center dr. |
boca raton FL |
|
Manufacturer (Section G) |
DONGGUAN HUIXAN ELECTRICAL PRODUCTS CO.LTD |
no. 9112, hung yeh 8th road |
|
tangxia town, dongguan |
CH
|
|
Manufacturer Contact |
tracie
jones
|
p.o. box 2931 |
wichita, KS 67201
|
3162197325
|
|
MDR Report Key | 5130897 |
MDR Text Key | 27668708 |
Report Number | 3003862163-2015-00128 |
Device Sequence Number | 1 |
Product Code |
KFZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other
|
Report Date |
09/08/2015 |
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 |
No Information
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 09/08/2015 |
Was Device Evaluated by Manufacturer? |
No
|
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 |
|
|