Brand Name | OXIBAND, PEDIATRIC/INFANT |
Type of Device | PULSE OXIMETER SENSOR |
Manufacturer (Section D) |
COVIDIEN |
blvd. insurgentes parcela #37 |
tijuana, bc |
MX |
|
Manufacturer (Section G) |
COVIDIEN |
blvd. insurgentes parcela #37 |
|
tijuana, bc |
MX
|
|
Manufacturer Contact |
thom
mcnamara
|
15 hampshire street |
mansfield, MA 02048
|
5084524811
|
|
MDR Report Key | 5258972 |
MDR Text Key | 32500842 |
Report Number | 2936999-2015-01021 |
Device Sequence Number | 1 |
Product Code |
DQA
|
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 |
consumer,health professional |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
11/10/2015 |
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 | OXI-P/I |
Device Catalogue Number | OXI-P/I |
Device Lot Number | 143460198XH |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/10/2015 |
Initial Date FDA Received | 12/01/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/14/2014 |
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 |
|
|