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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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COVIDIEN KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number 383400
Device Problems Display Difficult to Read (1181); No Display/Image (1183)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported to covidien that a customer had an issue with the enteral feeding pump.Upon triage on (b)(6) 2018.Service found the unit's screen was faded and illegible.
 
Manufacturer Narrative
An evaluation of the kangaroo pump was performed for a blank screen.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.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
KANGAROO
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
COVIDIEN
789 puxing rd
building 10
shanghai 20111 4
CN  201114
MDR Report Key7732844
MDR Text Key115592557
Report Number3006451981-2018-00534
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 10/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number383400
Device Catalogue Number383400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2018
Date Manufacturer Received08/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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