Brand Name | ENTERALITE INFINITY EFP |
Type of Device | ENTERAL FEEDING PUMP |
Manufacturer (Section D) |
MOOG MEDICAL DEVICES GROUP |
salt lake city UT |
|
Manufacturer Contact |
katherine
kenner, senior ras
|
4314 zevex park ln. |
salt lake city, UT 84123
|
|
MDR Report Key | 4203892 |
MDR Text Key | 5152070 |
Report Number | 1722139-2014-00124 |
Device Sequence Number | 1 |
Product Code |
LZH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K981816 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/23/2014 |
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 |
Other
|
Device Model Number | EFP |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 06/26/2014 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/18/2014 |
Initial Date FDA Received | 07/23/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/04/2007 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 23 YR |
Patient Weight | 51 |
|
|