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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEY,PUMP W/POLE CLMP; ENTERAL FEEDING PUMP

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COVIDIEN KANGAROO JOEY,PUMP W/POLE CLMP; ENTERAL FEEDING PUMP Back to Search Results
Model Number 383400
Device Problem Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Submit date: 10/31/2016.An investigation is currently underway.Upon completion, the results will be forwarded.
 
Event Description
It was reported to covidien on (b)(6) 2016 that a customer had an issue with an enteral feeding pump.The customer states that the unit shuts off intermittently.
 
Manufacturer Narrative
An evaluation of the kangaroo pump was performed for the reported condition that the keypad shutoff intermittently.The unit was triaged and the reported issue was confirmed.The pump was excessively damaged, so the root cause is categorized as customer misuse.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/POLE CLMP
Type of Device
ENTERAL FEEDING PUMP
Manufacturer (Section D)
COVIDIEN
building # 10, 789 puxing road
shanghai
CH 
Manufacturer (Section G)
COVIDIEN
building # 10, 789 puxing road
shanghai
CH  
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key6067800
MDR Text Key59048515
Report Number3006451981-2016-00548
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/17/2016
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 Number383400
Device Catalogue Number383400
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/17/2016
Initial Date FDA Received10/31/2016
Supplement Dates Manufacturer Received10/17/2016
Supplement Dates FDA Received10/13/2017
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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