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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEY,PUMP W/CLMP,REFB; PUMP, INFUSION, ENTERAL
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COVIDIEN KANGAROO JOEY,PUMP W/CLMP,REFB; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 383401
Device Problems Display or Visual Feedback Problem (1184); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Submit date: 2/16/17.
 
Event Description
It was reported to covidien that a customer had an issue with an enteral feeding pump.The customer reports error 33.Upon triage on (b)(6) 2017 the service tech found that the unit had an inconsistent display.
 
Manufacturer Narrative
The customer¿s reported condition was confirmed.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
KANGAROO JOEY,PUMP W/CLMP,REFB
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN
2824 airwest boulevard
plainfield IN 46168
MDR Report Key6335251
MDR Text Key67880640
Report Number3008361498-2017-00146
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 10/11/2018
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 Lay User/Patient
Device Model Number383401
Device Catalogue Number383401
Device Lot NumberF13013863
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/23/2017
Initial Date FDA Received02/16/2017
Supplement Dates Manufacturer Received01/23/2017
Supplement Dates FDA Received10/11/2018
Patient Sequence Number1
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