Brand Name | OXYGEN MASK HIGH CONCENTR. 7FT. TUBING REBREATHER ADULT 25/CA |
Type of Device | MASK, OXYGEN, NON-REBREATHING |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC. |
9124 polk lane |
suite 101 |
olive branch MS 38654 |
|
Manufacturer Contact |
lisa
perz
|
smiths medical asd, inc. |
6000 nathan lane north |
minneapolis,, MN 55442
|
7633833074
|
|
MDR Report Key | 6250556 |
MDR Text Key | 64776814 |
Report Number | 3012307300-2017-00167 |
Device Sequence Number | 1 |
Product Code |
KGB
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
12/19/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/13/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other Health Care Professional
|
Device Catalogue Number | 001123 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/19/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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) |
Death;
|