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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 382400
Device Problems No Audible Alarm (1019); Appropriate Term/Code Not Available (3191)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 07/03/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer states the enteral feeding unit had a buzzer/speaker failure.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The unit was triaged and the customer¿s reported condition was confirmed.A trend has been identified and a corrective and preventative 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
building 10- no 789 puxing roa
shanghai 20111 4
CN  201114
MDR Report Key7722509
MDR Text Key115273849
Report Number3006451981-2018-00526
Device Sequence Number1
Product Code LZH
UDI-Device Identifier10884521006614
UDI-Public10884521006614
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 10/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date12/03/2022
Device Model Number382400
Device Catalogue Number382400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2018
Date Manufacturer Received08/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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