ENTERALITE INFINITY ENTERAL FEEDING PUMP INFKIT2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-23 for ENTERALITE INFINITY ENTERAL FEEDING PUMP INFKIT2 manufactured by Moog Medical Devices Group.

Event Text Entries

[184483750] 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 severe fluid ingress, which caused the pump speaker and pcb to fail, resulting in the alarms failing to alarm audibly. The pump was repaired and returned to the customer.
Patient Sequence No: 1, Text Type: N, H10


[184483751] The initial reporter stated that the pump did not have any audible tones. 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


MAUDE Entry Details

Report Number1722139-2020-00097
MDR Report Key9865654
Report SourceUSER FACILITY
Date Received2020-03-23
Date of Report2020-02-28
Date of Event2020-02-27
Date Mfgr Received2020-02-28
Device Manufacturer Date2015-01-14
Date Added to Maude2020-03-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKRISTIN HARDESTY
Manufacturer Street4314 ZEVEX PARK LANE
Manufacturer CitySALT LAKE CITY, UT
Manufacturer CountryUS
Manufacturer Phone2641001112
Manufacturer G1MOOG MEDICAL DEVICES GROUP
Manufacturer Street4314 ZEVEX PARK LANE
Manufacturer CitySALT LAKE CITY, UT
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENTERALITE INFINITY ENTERAL FEEDING PUMP
Generic NameENTERAL INFUSION PUMP
Product CodeLZH
Date Received2020-03-23
Returned To Mfg2020-03-09
Model NumberINFKIT2
Catalog NumberINFKIT2
Lot NumberN/A
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMOOG MEDICAL DEVICES GROUP
Manufacturer Address4314 ZEVEX PARK LANE SALT LAKE CITY, UT US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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