Brand Name | 840 VENTILATOR |
Type of Device | CONTINUOUS VENTILATOR |
Manufacturer (Section D) |
COVIDIEN |
new mervue industrial park |
michael collins road |
galway |
EI |
|
Manufacturer (Section G) |
COVIDIEN |
new mervue industrial park |
michael collins road |
galway |
EI
|
|
Manufacturer Contact |
ray
maroofian
|
2101 faraday ave |
carlsbad, CA 92008
|
7606035334
|
|
MDR Report Key | 5985521 |
MDR Text Key | 56112188 |
Report Number | 8020893-2016-02546 |
Device Sequence Number | 1 |
Product Code |
CBK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K970460 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
09/08/2016 |
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? |
Yes
|
Initial Date Manufacturer Received |
09/08/2016
|
Initial Date FDA Received | 09/28/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/07/2002 |
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 |