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 |
|
MDR Report Key | 7658594 |
MDR Text Key | 113021753 |
Report Number | 3011137372-2018-00184 |
Device Sequence Number | 1 |
Product Code |
BTM
|
Combination Product (y/n) | N |
PMA/PMN Number | K964719 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
06/18/2018 |
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 Catalogue Number | 5372 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/18/2018 |
Initial Date FDA Received | 07/03/2018 |
Supplement Dates Manufacturer Received | 08/17/2018
|
Supplement Dates FDA Received | 08/17/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|