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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN KANGAROO; PUMP, INFUSION, ENTERAL
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COVIDIEN KANGAROO; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 382401
Device Problems No Audible Alarm (1019); Defective Component (2292)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 06/24/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer reports the pump buzzer is not working.Issue found during testing.No patient involved.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
An evaluation of the kangaroo pump was performed for the reported condition of, ¿that the unit has no alarm sound.¿ the unit was triaged and the customer¿s reported condition was confirmed.A trend has been identified and a corrective action has been opened to address this issue.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
KANGAROO
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN
2824 airwest blvd
plainfield IN 46168
MDR Report Key7690924
MDR Text Key114412824
Report Number3008361498-2018-00378
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,user f
Type of Report Initial,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number382401
Device Catalogue Number382401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2018
Date Manufacturer Received08/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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