Brand Name | RESUS,ADLT W/MSK,LRG TBG, P/O, 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 |
mindy
faber
|
75 north fairway drive |
vernon hills, IL 60061
|
|
MDR Report Key | 6457343 |
MDR Text Key | 71680103 |
Report Number | 8030673-2017-00316 |
Device Sequence Number | 1 |
Product Code |
OEV
|
Combination Product (y/n) | N |
Reporter Country Code | RP |
PMA/PMN Number | ENFORCEMENT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,health pr |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
08/04/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/04/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 2K8032 |
Device Lot Number | 0000816138 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/21/2017 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/04/2017 |
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;
|