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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 Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/24/2016
Event Type  malfunction  
Manufacturer Narrative
An investigation is currently underway.Upon completion, a full report shall be provided.
 
Event Description
It was reported to covidien on (b)(6) 2016 that the customer experienced an issue with an enteral feeding pump.The customer reports that the occlusion alarm did not occur during use on a patient.There was no patient harm or required medical intervention.
 
Manufacturer Narrative
An investigation of kangaroo joey pump was performed for the reported condition of; the unit¿s occlusion alarm did not occur during use on a patient.The unit was triaged and the complaint could not be confirmed.Kangaroo joey pump was manufactured in 2014.A review of the device history record shows this device was released meeting all manufacturing specifications.
 
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Brand Name
KANGAROO JOEY,PUMP W/POLE CLMP
Type of Device
ENTERAL FEEDING PUMP
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
Manufacturer (Section G)
COVIDIEN
15 hampshire street
mansfield MA 02048
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key5588420
MDR Text Key44016116
Report Number1282497-2016-00130
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/07/2016
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 04/07/2016
Initial Date FDA Received04/20/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/17/2016
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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