Brand Name | RESUS, ADLT W/MASK, 40" TBG, 6/CS |
Type of Device | MANUAL EMERGENCY VENTILATOR |
Manufacturer (Section D) |
CAREFUSION/BD |
cerrada vía de la producción |
no. 85 parque industrial |
mexicali baja california norte |
MX |
|
Manufacturer (Section G) |
CAREFUSION/BD |
cerrada vía de la producción |
no.85 parque industrial |
mexicali baja california norte |
MX
|
|
Manufacturer Contact |
jill
rittorno
|
22745 savi ranch parkway |
yorba linda, CA 92887
|
7149227830
|
|
MDR Report Key | 6001717 |
MDR Text Key | 56537264 |
Report Number | 8030673-2016-00240 |
Device Sequence Number | 1 |
Product Code |
OEV
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | ENFORCEMENT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
12/15/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 2K8005 |
Device Lot Number | 0000944395 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/06/2016 |
Initial Date FDA Received | 10/05/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 12/15/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Patient Outcome(s) |
Required Intervention;
|