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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 06/20/2023
Event Type  malfunction  
Event Description
The initial reporter stated that the pump would not turn on.They stated that this resulted in an approximately 4 hour delay of therapy and that the patient is unable to use an alternative method of feeding.Mmdg did follow up with the initial reporter who stated that the patient was stable and that they hadn't experienced any harm due to the complaint.(b)(4).
 
Manufacturer Narrative
The pump was not returned to mmdg for evaluation.A dhr review was completed and no non-conformances were found.Because the device was not returned to mmdg, an investigation could not be completed.This report is being filed for the reported delay in therapy that the patient experienced as a result of the complaint.
 
Event Description
The initial reporter stated that the pump would not turn on.They stated that this resulted in an approximately 4 hour delay of therapy and that the patient is unable to use an alternative method of feeding.Mmdg did follow up with the initial reporter who stated that the patient was stable and that they hadn't experienced any harm due to the complaint.(b)(4).
 
Manufacturer Narrative
The pump was returned to mmdg for evaluation.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.This report is being filed for the reported delay in therapy that the patient experienced as a result of the complaint.
 
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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
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 Key17344282
MDR Text Key319434275
Report Number1722139-2023-00368
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 06/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2023
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 Received06/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2009
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 Age22 MO
Patient SexMale
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