Brand Name | NELLCOR |
Type of Device | OXIMETER |
Manufacturer (Section D) |
NELLCOR PURITAN BENNETT MEXICO SA |
boulevard insurgentes 19030 |
tijuana 22225 |
MX 22225 |
|
Manufacturer (Section G) |
NELLCOR PURITAN BENNETT MEXICO SA |
boulevard insurgentes 19030 |
|
tijuana 22225 |
MX
22225
|
|
Manufacturer Contact |
sharon
murphy
|
15 hampshire street |
mansfield, MA 02048
|
2034925267
|
|
MDR Report Key | 6679767 |
MDR Text Key | 78761515 |
Report Number | 9610849-2017-05007 |
Device Sequence Number | 1 |
Product Code |
DQA
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
PMA/PMN Number | K944760 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Physician
|
Remedial Action |
Notification |
Type of Report
| Initial |
Report Date |
06/02/2017 |
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 Model Number | D-YS |
Device Catalogue Number | D-YS |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/02/2017 |
Initial Date FDA Received | 06/29/2017 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Required Intervention;
|
|
|