Brand Name | 840 VENTILATOR |
Type of Device | VENTILATOR, CONTINUOUS, FACILITY USE |
Manufacturer (Section D) |
NELLCOR PURITAN BENNETT IRELAND |
micheal collins rd mervue |
galway |
|
Manufacturer (Section G) |
NELLCOR PURITAN BENNETT IRELAND |
micheal collins rd mervue |
|
galway |
|
Manufacturer Contact |
kelly
adams
|
2101 faraday avenue |
carlsbad, CA 92008
|
7606035046
|
|
MDR Report Key | 7370316 |
MDR Text Key | 103527491 |
Report Number | 8020893-2018-00153 |
Device Sequence Number | 1 |
Product Code |
CBK
|
UDI-Device Identifier | 10884522019354 |
UDI-Public | 10884522019354 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K151252 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/26/2018 |
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 |
Health Professional
|
Device Model Number | 840 |
Device Catalogue Number | 4-840120DIUU-US |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/28/2018 |
Initial Date FDA Received | 03/26/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 05/28/2008 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|