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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY ORANGE ENTERAL FEEDING PUMP; ENTERAL INFUSION PUMP
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MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY ORANGE ENTERAL FEEDING PUMP; ENTERAL INFUSION PUMP Back to Search Results
Model Number INFORNG
Device Problem Fire (1245)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2022
Event Type  malfunction  
Manufacturer Narrative
The pump was returned to mmdg for evaluation.A dhr review was completed and found no non conformances.The device was returned to mmdg, but at the time of this report, the investigation was not completed.This report will be updated when the investigation information is available.
 
Event Description
The initial reporter stated that they observed "smoking when plugged in".They were unclear if this was coming from the pump, the charger, or a different source.At the time of the complaint the initial reporter advised that they had no other information they were willing to provide.They stated that there had been no adverse effect to the patient.(b)(4).
 
Manufacturer Narrative
The pump was returned to mmdg for evaluation.A dhr review was completed and found no non conformances.When the investigation was completed, there was no indication that the complaint had occurred as reported.There was no visible damage to the device and no evidence that the pump had been smoking or showed evidence of sparks or fire.The device was noted to smell heavily of cigarette smoke.The pump was serviced and returned to the customer.
 
Event Description
The initial reporter stated that they observed "smoking when plugged in".They were unclear if this was coming from the pump, the charger, or a different source.At the time of the complaint the initial reporter advised that they had no other information they were willing to provide.They stated that there had been no adverse effect to the patient.(b)(4).
 
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Brand Name
ENTERALITE INFINITY ORANGE 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 Key15849327
MDR Text Key304165951
Report Number1722139-2022-01129
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 10/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberINFORNG
Device Catalogue NumberINFORNG
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/23/2018
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 Age11 YR
Patient SexFemale
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