Brand Name | HUDSON CONCHATHERM NEPTUNE, DUAL THERMISTOR |
Type of Device | ELECRONIC THERMOMETER |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
research triangle park NC |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
rancho el descanso |
|
tecate 21478 |
MX
21478
|
|
Manufacturer Contact |
margie
burton, rn
|
3015 carrington mill blvd |
morrisville, NC 27560
|
9194334965
|
|
MDR Report Key | 5500294 |
MDR Text Key | 40328237 |
Report Number | 3003898360-2016-00294 |
Device Sequence Number | 1 |
Product Code |
FLL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Respiratory Therapist
|
Type of Report
| Initial |
Report Date |
03/08/2016 |
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 | 395-90 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/08/2016 |
Initial Date FDA Received | 03/15/2016 |
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 |
Treatment | NON-HEATED WIRE CIRCUIT.NEPTUNE |