MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-31 for ENTERALITE INFINITY ENTERAL FEEDING PUMP INFKIT2 manufactured by Moog Medical Devices Group.
[185900353]
The device was not returned to mmdg for evaluation. A dhr was performed and found no nonconformances. Because the device was not returned, mmdg has been unable to investigate or confirm the complaint. This report will be updated if the device is returned to mmdg.
Patient Sequence No: 1, Text Type: N, H10
[185900414]
The initial reporter states that the pump appeared to be running, but was not delivering. They stated that there were no alarms. Mmdg followed up with the initial reporter, who stated that the patient had experienced a delay in therapy, but had not had any adverse effects due to the complaint. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722139-2020-00110 |
| MDR Report Key | 9904553 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2018-02-14 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KRISTIN HARDESTY |
| Manufacturer Street | 4314 ZEVEX PARK LANE |
| Manufacturer City | SALT LAKE CITY, UT |
| Manufacturer Country | US |
| Manufacturer Phone | 2641001112 |
| Manufacturer G1 | MOOG MEDICAL DEVICES GROUP |
| Manufacturer Street | 4314 ZEVEX PARK LANE |
| Manufacturer City | SALT LAKE CITY, UT |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTERALITE INFINITY ENTERAL FEEDING PUMP |
| Generic Name | ENTERAL INFUSION PUMP |
| Product Code | LZH |
| Date Received | 2020-03-31 |
| Model Number | INFKIT2 |
| Catalog Number | INFKIT2 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOOG MEDICAL DEVICES GROUP |
| Manufacturer Address | 4314 ZEVEX PARK LANE SALT LAKE CITY, UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |