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 840 VENTILATOR; CONTINUOUS VENTILATOR
  • 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 840 VENTILATOR; CONTINUOUS VENTILATOR Back to Search Results
Model Number 840
Device Problems Sticking (1597); Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 12/26/2014
Event Type  malfunction  
Event Description
A report was received stating that a key on the ventilator graphic unser interface keyboard was stuck and unresponsive.There was no patient involved at the time of the event.
 
Manufacturer Narrative
The covidien customer support engineer (cse) evaluated the device and found the ventilator keypad to have a short.The keypad was replaced to resolve the issue.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
840 VENTILATOR
Type of Device
CONTINUOUS VENTILATOR
Manufacturer (Section D)
COVIDIEN
new mervue industrial park
michael collins road
galway
EI 
Manufacturer (Section G)
COVIDIEN
new mervue industrial park
michael collins road
galway
EI  
Manufacturer Contact
denise braxton
6135 gunbarrel avenue
boulder, CO 80301
3038768909
MDR Report Key4415273
MDR Text Key5276946
Report Number8020893-2015-00025
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K970460
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/26/2014
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 Number840
Device Catalogue Number840
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/26/2014
Initial Date FDA Received01/13/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-