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 Problem No Display/Image (1183)
Patient Problem No Patient Involvement (2645)
Event Date 05/22/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer reported the enteral feeding pump¿s image was distorted on the screen during testing.Upon follow up the customer said the image was blurry.Upon triage, service verified that the display was blank.
 
Manufacturer Narrative
An evaluation of the kangaroo joey pump was performed and the customer states ¿the enteral feeding pump¿s image was distorted on the screen during testing.¿ the unit was triaged and the customer¿s reported condition was confirmed.The pump¿s display was completely blank.A fracture was found on the lcd glass behind the black epoxy causing the display to be blank.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 Key7641657
MDR Text Key112457599
Report Number3008361498-2018-00356
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 09/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2018
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 Manufacturer06/08/2018
Date Manufacturer Received05/31/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-