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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHANGHAI KANGAROO EPUMP - RFB; ENTERAL FEEDING PUMP

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SHANGHAI KANGAROO EPUMP - RFB; ENTERAL FEEDING PUMP Back to Search Results
Model Number 382401
Device Problem Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Submit date: 09/29/2016.An investigation is currently underway.Upon completion, the results will be forwarded.
 
Event Description
It was reported to covidien on (b)(6) 2016 that the customer experienced an issue with an enteral feeding pump.The customer reports that the unit has intermittent power.
 
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 and the customer states ¿the unit turns on and off by its own.¿ the unit was triaged and 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 EPUMP - RFB
Type of Device
ENTERAL FEEDING PUMP
Manufacturer (Section D)
SHANGHAI
building # 10, 789 puxing road
shanghai
CH 
MDR Report Key5988535
MDR Text Key56355344
Report Number3006451981-2016-00452
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,Followup
Report Date 10/04/2018
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 No Information
Device Model Number382401
Device Catalogue Number382401
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/21/2016
Initial Date FDA Received09/29/2016
Supplement Dates Manufacturer Received06/21/2016
08/08/2018
Supplement Dates FDA Received07/31/2018
10/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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