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 Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/26/2022
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to mmdg for investigation.A dhr review was completed and no non-conformances were found.Because the device was not returned to mmdg for evaluation, an investigation could not be completed.This report will be updated if the device is returned to mmdg.
 
Event Description
The initial reporter stated that the pump was not alarming when the dose was done.They stated that the pump also didn't deliver all the time.They also stated that they had no information about the pump settings for the dose done alarm.Mmdg followed up with the initial reporter, who stated that there had been no adverse effect to the patient.No further information was provided.Complaint: (b)(4).
 
Manufacturer Narrative
The device was returned to mmdg for investigation.A dhr review was completed and no non-conformances were found.When the device was returned to mmdg for investigation, the pump operated as expected.Mmdg could not replicate or confirm the reported complaint.Based on this information, no mdr would have been required.
 
Event Description
The initial reporter stated that the pump was not alarming when the dose was done.They stated that the pump also didn't deliver all the time.They also stated that they had no information about the pump settings for the dose done alarm.Mmdg followed up with the initial reporter, who stated that there had been no adverse effect to the patient.No further information was provided.(b)(4).
 
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
Manufacturer (Section G)
MOOG MEDICAL DEVICES GROUP
4314 zevex park lane
salt lake city UT 84123
Manufacturer Contact
kristin egelhoff
4314 zevex park lane
salt lake city, UT 84123
8012641001
MDR Report Key16432489
MDR Text Key310271172
Report Number1722139-2023-00144
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2023
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/03/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age14 YR
Patient SexMale
-
-