Brand Name | MANUAL CONTROLLED INFANT WARMER |
Type of Device | FMT |
Manufacturer (Section D) |
FISHER & PAYKEL HEALTHCARE LTD |
15 maurice paykel place |
east tamaki |
auckland, 2013 |
NZ 2013 |
|
Manufacturer (Section G) |
FISHER & PAYKEL HEALTHCARE LTD |
15 maurice paykel place |
east tamaki |
auckland, 2013 |
NZ
2013
|
|
Manufacturer Contact |
raymond
yan
|
173 technology drive |
suite 100 |
irvine, CA 92618
|
9494534000
|
|
MDR Report Key | 5811196 |
MDR Text Key | 50066908 |
Report Number | 9611451-2016-00343 |
Device Sequence Number | 1 |
Product Code |
FMT
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K971461 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,other,user facility |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
06/22/2016 |
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 | IW990 |
Device Catalogue Number | IW990 |
Device Lot Number | 020110 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/22/2016 |
Initial Date FDA Received | 07/20/2016 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 01/10/2002 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|