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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 Consequences Or Impact To Patient (2199)
Event Date 05/26/2020
Event Type  malfunction  
Manufacturer Narrative
The pump was not returned to mmdg for evaluation.A dhr review was performed 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 turn on.They stated that this resulted in a 6 hour delay of therapy.Mmdg did follow up with the initial reporter, who stated that the patient had not experienced any adverse effects due to the reported complaint and delay in therapy.(b)(4).
 
Manufacturer Narrative
The pump was returned to mmdg for evaluation.A dhr review was performed and found no non conformances.When the pump was returned to mmdg, it would not turn on.The pump was unable to turn on because the pcb was damaged.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 6 hour delay of therapy.Mmdg did follow up with the initial reporter, who stated that the patient had not experienced any adverse effects due to the reported complaint and delay in therapy.(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
MDR Report Key10186748
MDR Text Key196246278
Report Number1722139-2020-00257
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 05/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2020
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 Manufacturer06/24/2020
Date Manufacturer Received05/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age7 YR
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