Brand Name | NELLCOR |
Type of Device | OXIMETER |
Manufacturer (Section D) |
NELLCOR PURITAN BENNETT MEXICO SA |
boulevard insurgentes 19030 |
tijuana,bc 22225 |
MX 22225 |
|
Manufacturer (Section G) |
NELLCOR PURITAN BENNETT MEXICO SA |
boulevard insurgentes 19030 |
|
tijuana,bc 22225 |
MX
22225
|
|
Manufacturer Contact |
avi
kluger
|
15 hampshire st. |
mansfield, MA 02048
|
3035306582
|
|
MDR Report Key | 7421002 |
MDR Text Key | 105123313 |
Report Number | 2936999-2018-00257 |
Device Sequence Number | 1 |
Product Code |
DQA
|
UDI-Device Identifier | 10884522039710 |
UDI-Public | 10884522039710 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K012891 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
04/11/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/11/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | MAXFAST |
Device Catalogue Number | MAXFAST |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/29/2018 |
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) |
Other;
|
Patient Age | 50 YR |
|
|