Brand Name | ENTERALITE INFINITY ENTERAL INFUSION PUMP |
Type of Device | ENTERAL INFUSION PUMP |
Manufacturer (Section D) |
MOOG MEDICAL DEVICES GROUP |
4314 zevex park lane |
salt lake city, ut |
|
Manufacturer (Section G) |
MOOG MEDICAL DEVICES GROUP |
4314 zevex park lane |
|
salt lake city, ut |
|
Manufacturer Contact |
kristin
hardesty
|
4314 zevex park lane |
salt lake city, ut
|
2641001112
|
|
MDR Report Key | 10272724 |
MDR Text Key | 199681473 |
Report Number | 1722139-2020-00301 |
Device Sequence Number | 1 |
Product Code |
LZH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K031199 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
06/18/2020 |
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 | INFKIT2 |
Device Catalogue Number | INFKIT2 |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/18/2020 |
Initial Date FDA Received | 07/14/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/19/2020 |
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 | 3 MO |