MAUDE Adverse Event Report: COVIDIEN 840 VENT USA

Model Number 840

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2014

Event Type  Injury  

Event Description

A report was received from the usa indicating that during patient use, the key was stuck on the graphic user interface (gui) board on the device.The patient was transferred to another ventilator as a result.There were no negative pt effects reported.Though requested, no add'l info was available.

Manufacturer Narrative

The customer support engineer (cse) inspected the device and verified the malfunction.The device exhibited code zb0052 (gui key stuck).The cse replaced the graphic user interface (gui) keyboard.Upon further inspection it was noted that the gui latch was broken.The latch was replaced.The device was then tested and passed extended self-testing (est), short self-test (sst) and electrical safety testing.The device then met manufacture specifications.The service history record (shr)for this device was reviewed for similar complaint modes.No service history record.Complaint trends will continue to be monitored.Should add'l info become available, a supplemental report will be submitted.(b)(4).

• Brand Name: 840 VENT USA
• 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 ave; boulder, CO 80301 ; 3038768909
• MDR Report Key: 3701012
• MDR Text Key: 4230116
• Report Number: 8020893-2014-00592
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 840
• Device Catalogue Number: 840
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2014
• Initial Date FDA Received: 03/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention