Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 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 KANGAROO; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 383400
Device Problems Break (1069); Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Date 02/15/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that an issue occurred with an enteral feeding pump.Follow up received from the customer on (b)(6) 2018 stated the live pin on the ac connector was broken.
 
Manufacturer Narrative
An evaluation of the kangaroo joey pump was performed and the customer states ¿unit has broken pin in the ac connector socket.Follow up received from the customer on (b)(6) 2018 stated the live pin on the ac connector was broken.¿ 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
KANGAROO
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN
2824 airwest blvd
plainfield IN 46168
MDR Report Key7465741
MDR Text Key106655080
Report Number3008361498-2018-00239
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
Report Date 09/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number383400
Device Catalogue Number383400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2018
Date Manufacturer Received04/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-