Brand Name | PANDA IRES WARMER |
Type of Device | WARMER, INFANT RADIANT |
Manufacturer (Section D) |
DATEX-OHMEDA, INC. |
3030 ohmeda dr, |
madison, WI 53718 |
|
Manufacturer (Section G) |
DATEX-OHMEDA, INC. |
3030 ohmeda dr, |
|
madison, WI 53718 |
|
Manufacturer Contact |
|
MDR Report Key | 12751852 |
MDR Text Key | 281219977 |
Report Number | 2112667-2021-02437 |
Device Sequence Number | 1 |
Product Code |
BSZ
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K122267 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
11/04/2021 |
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 | M1112198 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/06/2021 |
Initial Date FDA Received | 11/04/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/06/2013 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
A
|
Patient Sequence Number | 1 |
|
|