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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG PLAINFIELD KANGAROO; PUMP, INFUSION, ENTERAL

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COVIDIEN MFG PLAINFIELD KANGAROO; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 382400
Device Problem Temperature Problem (3022)
Patient Problem No Patient Involvement (2645)
Event Date 05/02/2017
Event Type  malfunction  
Manufacturer Narrative
Submit date: 2-jun-2017.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The unit was sent to a service center for repair.Upon triage, a technician was unable to confirm the allegation.The unit's software was updated and the unit was cleaned, tested and recertified per procedure.The unit was restored to proper operation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer reports the device was being returned due to warming.No additional information given.No patient involved in this case.
 
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Brand Name
KANGAROO
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN MFG PLAINFIELD
2824 airwest blvd
plainfield IN 46168
Manufacturer (Section G)
COVIDIEN MFG PLAINFIELD
2824 airwest blvd
plainfield IN 46168
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key6608048
MDR Text Key76526093
Report Number3008361498-2017-05168
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/03/2017
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 Expiration Date03/25/2014
Device Model Number382400
Device Catalogue Number382400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2017
Initial Date Manufacturer Received 05/03/2017
Initial Date FDA Received06/02/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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