MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-09 for ENTERALITE INFINITY ENTERAL FEEDING PUMP INFKIT2 manufactured by Moog Medical Devices Group.
[183015960]
The pump was returned to mmdg for evaluation. A dhr review was completed and found no non conformances. During the investigation mmdg found that the pump had a failed speaker, which caused the pump to not alarm audibly. The pump was repaired and returned to the customer.
Patient Sequence No: 1, Text Type: N, H10
[183015961]
The initial reporter stated that the pump did not have any audible tones when turned on. The initial reporter also stated that this occurred during testing, and no patient had been involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722139-2020-00086 |
| MDR Report Key | 9808222 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-09 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2019-12-16 |
| Date Added to Maude | 2020-03-09 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 2020-03-09 |
| Returned To Mfg | 2020-02-20 |
| Model Number | INFKIT2 |
| Catalog Number | INFKIT2 |
| Lot Number | N/A |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-09 |