Brand Name | HUDSON CONCHA NEPTUNE |
Type of Device | HEATED HUMIDIFICATION SYSTEM |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
tecate |
MX |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
prolongacion mision eusebio |
kino # 1316,rancho el descanso |
tecate, b.c., c.p. 2147 8 |
MX
21478
|
|
Manufacturer Contact |
margie
burton, rn
|
po box 12600 |
durham, NC 27709
|
9194334965
|
|
MDR Report Key | 3647312 |
MDR Text Key | 16803214 |
Report Number | 3003898360-2014-00012 |
Device Sequence Number | 1 |
Product Code |
BZE
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
12/13/2013 |
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 |
Other
|
Device Catalogue Number | 425-00 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/13/2013 |
Initial Date FDA Received | 01/06/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/01/2008 |
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 |
Treatment | PB VENTILATOR |
|
|