Brand Name | HUDSON CONCHATHERM NEPTUNE, DUAL THERMISTOR |
Type of Device | HUMIDIFIER, RESPIRATORY GAS, ( |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
research triangle park NC |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
rancho el descanso |
|
tecate 21478 |
MX
21478
|
|
Manufacturer Contact |
katharine
tarpley
|
3015 carrington mill blvd |
morrisville, NC 27560
|
9194334854
|
|
MDR Report Key | 8604044 |
MDR Text Key | 144836552 |
Report Number | 3003898360-2019-00551 |
Device Sequence Number | 1 |
Product Code |
BTT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K063758 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/18/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/13/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Catalogue Number | 395-90 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 04/18/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |