Brand Name | HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER |
Type of Device | VENTILATOR, EMERGENCY, MANUAL |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
research triangle park NC |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
3015 carrington mill blvd |
|
morrisville NC 27560 |
|
Manufacturer Contact |
katharine
tarpley
|
3015 carrington mill blvd |
morrisville, NC 27560
|
9194334854
|
|
MDR Report Key | 7174852 |
MDR Text Key | 96730873 |
Report Number | 3011137372-2018-00014 |
Device Sequence Number | 1 |
Product Code |
BTM
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K964719 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
12/21/2017 |
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 |
No Information
|
Device Expiration Date | 08/08/2019 |
Device Catalogue Number | 5372 |
Device Lot Number | 160808 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/09/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/21/2017 |
Initial Date FDA Received | 01/09/2018 |
Supplement Dates Manufacturer Received | 02/07/2018
|
Supplement Dates FDA Received | 02/12/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
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 |