Brand Name | BABY RX05 OXY W/HR |
Type of Device | BLOOD GAS OXYGENATOR |
Manufacturer (Section D) |
TERUMO CORPORATION, ASHITAKA |
150 maimaigi-cho |
fujinomiya city |
shizuoka |
JA |
|
Manufacturer (Section G) |
TERUMO CORPORATION, ASHITAKA |
150 maimaigi-cho |
|
fujinomiya, shizuoka |
JA
|
|
Manufacturer Contact |
eileen
dorsey, manager
|
125 blue ball rd |
elkton, MD 21921
|
8002623304
|
|
MDR Report Key | 3810779 |
MDR Text Key | 4387986 |
Report Number | 9681834-2014-00082 |
Device Sequence Number | 1 |
Product Code |
DTZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K130493 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative,Distributor |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
03/05/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/21/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/30/2015 |
Device Model Number | 1CX*RX05RW |
Device Lot Number | 121215 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Device Age | 15 MO |
Event Location |
Hospital
|
Date Manufacturer Received | 03/05/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/15/2012 |
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 |
|
|