Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY ENTERAL FEEDING PUMP; ENTERAL INFUSION PUMP
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 02/16/2021
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 device was not returned to mmdg, no investigation could be completed.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 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).
 
Event Description
The initial reporter stated that the pump would not 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.[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 device was returned to mmdg, it was found to have a failed thermistor, which results in the pump battery not charging correctly.The pump is able to operate as expected when plugged in.The device was serviced to correct the issue.This report was filed for the delay in therapy the patient experienced.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11485941
MDR Text Key240612751
Report Number1722139-2021-00171
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 consumer
Type of Report Initial,Followup
Report Date 02/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2021
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 Manufacturer03/15/2021
Date Manufacturer Received02/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age7 YR
-
-