Brand Name | VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) |
Type of Device | VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) |
Manufacturer (Section D) |
SMITHS MEDICAL ASD,INC |
6000 nathan lane |
minneapolis, mn |
|
MDR Report Key | 10235431 |
MDR Text Key | 198289787 |
Report Number | 3012307300-2020-06650 |
Device Sequence Number | 1 |
Product Code |
BTM
|
UDI-Device Identifier | 00351688431219 |
UDI-Public | 0351688431219 |
Combination Product (y/n) | N |
PMA/PMN Number | K014115 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Type of Report
| Initial |
Report Date |
07/06/2020 |
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 Model Number | ADULT RESUSITATOR, ADULT MASK, BAG, OXY. RESERVOIR, FLOW DIVERTER 12/CA |
Device Catalogue Number | 8500 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/29/2020 |
Initial Date Manufacturer Received |
06/08/2020 |
Initial Date FDA Received | 07/06/2020 |
Was Device Evaluated by Manufacturer? |
No
|
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 |
|
|