Brand Name | HOLMES |
Type of Device | HUMIDIFIER |
Manufacturer (Section D) |
SUNBEAM PRODUCTS, INC. |
2381 executive center dr. |
boca raton, fl |
|
MDR Report Key | 9915296 |
MDR Text Key | 187120845 |
Report Number | 3003862163-2020-00022 |
Device Sequence Number | 1 |
Product Code |
KFZ
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Type of Report
| Initial,Followup |
Report Date |
04/09/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/02/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | HM5082 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/07/2020 |
Date Manufacturer Received | 04/07/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|