Brand Name | HUDSON VENTILATOR TUBING SET, LONG LENGTH |
Type of Device | BREATHING CIRCUIT |
Manufacturer (Section D) |
TELEFLEX |
nuevo laredo, tamaulipas |
MX |
|
Manufacturer Contact |
margie
burton, rn
|
po box 12600 |
durham, NC 27709
|
9194334965
|
|
MDR Report Key | 3955712 |
MDR Text Key | 4561270 |
Report Number | 3004365956-2014-00225 |
Device Sequence Number | 1 |
Product Code |
CAG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
05/21/2014 |
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 Catalogue Number | 1607 |
Device Lot Number | 02M1300227 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/21/2014 |
Initial Date FDA Received | 06/12/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/01/2013 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | PURITAN BENNETT FILTER; PURITAN BENNETT VENTILATOR |