Brand Name | SUNBEAM |
Type of Device | HUMIDIFIER |
Manufacturer (Section D) |
SUNBEAM PRODUCTS, INC. |
2381 executive center dr. |
boca raton FL 33431 |
|
Manufacturer (Section G) |
CHUZHOU DONLIM ELECTRICAL APPLIANCES CO.,LTD. |
no.1777 yangzi east road |
|
chuzhou, anhui 23900 0 |
CH
239000
|
|
Manufacturer Contact |
michael
miles
|
303 nelson ave. |
neosho, MO 64850
|
4174557441
|
|
MDR Report Key | 12968060 |
MDR Text Key | 283516604 |
Report Number | 3010341502-2021-00084 |
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
|
Type of Report
| Initial,Followup |
Report Date |
12/16/2021 |
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 |
Lay User/Patient
|
Device Model Number | SWM6000 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/14/2021 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 12/09/2021 |
Supplement Dates Manufacturer Received | 12/14/2021
|
Supplement Dates FDA Received | 12/15/2021
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/15/2015 |
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 |
Patient Sex | Male |
|
|