Brand Name | MISTRAL-AIR PLUS (115V) BLOWER |
Type of Device | SYSTEM, THERMAL REGULATING |
Manufacturer (Section D) |
TSCI BV DBA THE 37COMPANY |
beeldschermweg 6f |
ah amersfoort 03821 |
NL 03821 |
|
Manufacturer (Section G) |
TSCI BV DBA THE 37COMPANY |
beeldschermweg 6f |
|
ah amersfoort 03821 |
NL
03821
|
|
Manufacturer Contact |
brian
thompson
|
3800 east centre avenue |
portage, MI 49002
|
2693292100
|
|
MDR Report Key | 10334458 |
MDR Text Key | 202362458 |
Report Number | 3003312341-2020-00004 |
Device Sequence Number | 1 |
Product Code |
DWJ
|
UDI-Device Identifier | ET37MA1100PM03 |
UDI-Public | +ET37MA1100PM03 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K101705 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/28/2020 |
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
|
Device Model Number | MA1100-PM |
Device Catalogue Number | MA1100-PM |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
07/02/2020 |
Initial Date FDA Received | 07/28/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 03/03/2016 |
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 |