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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY ENTERAL FEEDING PUMP; ENTERAL INFUSION PUMP
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MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY ENTERAL FEEDING PUMP; ENTERAL INFUSION PUMP Back to Search Results
Model Number INFKIT2
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
Event Type  malfunction  
Manufacturer Narrative
The pump was not returned to mmdg for evaluation.A dhr review was completed and found no non-conformances.Because the pump was not returned mmdg was not able to investigate or confirm the complaint.This report is being filed for the delay in therapy that the patient experienced due to the complaint.
 
Event Description
The initial reporter stated that the pump would not charge or turn on.They stated that this resulted in a delay in their feeding overnight.They stated that the patient does not have any other feeding methods available.Mmdg did follow up with the initial reporter, who stated that the patient had not experienced any adverse effects due to the complaint.(b)(4).
 
Manufacturer Narrative
The pump was returned to mmdg for evaluation.A dhr review was completed and found no non-conformances.When the pump was returned to mmdg for investigation, the pump was found to have a failed thermistor.This kept the battery from charging correctly.The pump was found to alarm low battery as expected.This report is being filed for the delay in therapy that the patient experienced due to the complaint.
 
Event Description
The initial reporter stated that the pump would not charge or turn on.They stated that this resulted in a delay in their feeding overnight.They stated that the patient does not have any other feeding methods available.Mmdg did follow up with the initial reporter, who stated that the patient had not experienced any adverse effects due to the complaint.(b)(4).
 
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Brand Name
ENTERALITE INFINITY ENTERAL FEEDING PUMP
Type of Device
ENTERAL INFUSION PUMP
Manufacturer (Section D)
MOOG MEDICAL DEVICES GROUP
4314 zevex park lane
salt lake city UT 84123
MDR Report Key11197679
MDR Text Key227742795
Report Number1722139-2021-00049
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
PMA/PMN Number
K031199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberINFKIT2
Device Catalogue NumberINFKIT2
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2021
Date Manufacturer Received12/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age2 YR
Patient Weight10
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