Brand Name | HEMOTHERM |
Type of Device | HEATER-COOLER DEVICE |
Manufacturer (Section D) |
GENTHERM MEDICAL, LLC |
12011 mosteller |
cincinnati OH 45241 |
|
Manufacturer (Section G) |
GENTHERM MEDICAL, LLC |
12011 mosteller |
|
cincinnati OH 45241 |
|
Manufacturer Contact |
christina
miracle
|
12011 mosteller |
cincinnati, OH 45241
|
8009897373
|
|
MDR Report Key | 9290181 |
MDR Text Key | 204457097 |
Report Number | 1516825-2019-00013 |
Device Sequence Number | 1 |
Product Code |
DWC
|
UDI-Device Identifier | 10613031860221 |
UDI-Public | (01)10613031860221 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K122813 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup |
Report Date |
11/07/2019 |
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 | 400CE |
Device Catalogue Number | N/A |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/08/2019 |
Initial Date FDA Received | 11/07/2019 |
Supplement Dates Manufacturer Received | 11/12/2019
|
Supplement Dates FDA Received | 03/28/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
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 |
|
|