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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN KANGAROO EPUMP - NEW; PUMP, INFUSION, ENTERAL
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COVIDIEN KANGAROO EPUMP - NEW; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 382400
Device Problem Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Submit date: 11/28/2016.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.During triage, it was found that the unit would power on/off intermittently.
 
Manufacturer Narrative
The unit was triaged and the reported condition was confirmed.The power cycle issue is due to a faulty membrane overlay.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 EPUMP - NEW
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN
building # 10, 789 puxing road
shanghai
CH 
MDR Report Key6128495
MDR Text Key61202782
Report Number3006451981-2016-00611
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
Type of Report Initial,Followup
Report Date 09/05/2018
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 Number382400
Device Catalogue Number382400
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 07/12/2016
Initial Date FDA Received11/28/2016
Supplement Dates Manufacturer Received07/12/2016
Supplement Dates FDA Received09/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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