• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN MFG PLAINFIELD KANGAROO; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 382401
Device Problem Device Stops Intermittently (1599)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Submit date: 2017-06-28.
 
Event Description
The customer unit was returned for routine maintenance.Upon triage, the unit shut off and had intermittent power during the recertification test.No patient injury reported.
 
Manufacturer Narrative
An evaluation of the kangaroo pump was performed for the reported condition of shut off and had intermittent power during recertification test.The unit was triaged and the reported issue was confirmed.The pump was excessively damaged, so the root cause is categorized as customer misuse.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6672959
MDR Text Key78576697
Report Number3008361498-2017-05236
Device Sequence Number1
Product Code LZH
UDI-Device Identifier10884521006621
UDI-Public10884521006621
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/08/2017
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 Health Professional
Device Model Number382401
Device Catalogue Number382401
Device Lot NumberC0716237
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/02/2017
Initial Date FDA Received06/28/2017
Supplement Dates Manufacturer Received10/19/2017
Supplement Dates FDA Received11/08/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-