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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY AC ADAPTER; INFUSION PUMP, ENTERAL

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MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY AC ADAPTER; INFUSION PUMP, ENTERAL Back to Search Results
Model Number 23401-001
Device Problem Electrical Power Problem (2925)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/04/2018
Event Type  malfunction  
Manufacturer Narrative
The device was returned to mmdg for evaluation.During the investigation mmdg was able to confirm the complaint.The charger housing had heated up and been burned by a faulty resistor.This report is being filed because per our procedures all reports of this type of event are considered reportable.
 
Event Description
The initial reporter stated that "heat was dissipated" from the power cord and that it had resulted in a burn hole forming in the housing of the charger.Mmdg made multiple follow up attempts to obtain additional information from the initial reporter regarding the complaint, however, no further information was made available.(b)(4).
 
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Brand Name
ENTERALITE INFINITY AC ADAPTER
Type of Device
INFUSION PUMP, ENTERAL
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 hardesty
4314 zevex park lane
salt lake city, UT 84123
8012641001
MDR Report Key8034611
MDR Text Key126370561
Report Number1722139-2018-00259
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 Administrator/Supervisor
Type of Report Initial
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number23401-001
Device Catalogue Number23401-001
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2018
Initial Date Manufacturer Received 10/04/2018
Initial Date FDA Received11/02/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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