Brand Name | CLEAR-THERM 3 HMEF |
Type of Device | FILTER, BACTERIAL, BREATHING-CIRCUIT |
Manufacturer (Section D) |
INTERSURGICAL LIMITED GUERNSEY |
circuit house, pitronnerie rd |
st. peter port, guernsey channel islands GY12R L |
UK GY12RL |
|
Manufacturer Contact |
ivan
seniut
|
arnioniu 60/28-1 |
pabrade, vilniaus apskritis, lt-4710
|
LH
|
|
MDR Report Key | 9292786 |
MDR Text Key | 165948658 |
Report Number | 1319447-2019-00002 |
Device Sequence Number | 1 |
Product Code |
CAH
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K024270 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
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? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Device Model Number | 1541000 |
Device Lot Number | 2191371 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Device Age | 1 YR |
Event Location |
Hospital
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 11/07/2019 |
Was Device Evaluated by Manufacturer? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|