Brand Name | HEMOTHERM |
Type of Device | HEATER-COOLER, PRODUCT CODE: DWC |
Manufacturer (Section D) |
GENTHERM MEDICAL, LLC |
12011 mosteller rd |
cincinnati OH 45241 |
|
Manufacturer (Section G) |
GENTHERM MEDICAL, LLC |
12011 mosteller rd |
|
cincinnati OH 45241 |
|
Manufacturer Contact |
angie
gegner
|
12011 mosteller rd |
cincinnati, OH 45241
|
5133265228
|
|
MDR Report Key | 15605327 |
MDR Text Key | 302855060 |
Report Number | 1516825-2022-00007 |
Device Sequence Number | 1 |
Product Code |
DWC
|
UDI-Device Identifier | 10613031860238 |
UDI-Public | (01)10613031860238 |
Combination Product (y/n) | Y |
Reporter Country Code | JA |
PMA/PMN Number | K122813 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/14/2022 |
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 Model Number | 400CE |
Device Catalogue Number | 86023 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
09/15/2022 |
Initial Date FDA Received | 10/14/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/23/2020 |
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 |
|
|