MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR

Model Number 840

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2014

Event Type  Injury  

Event Description

A report received from the usa stated an 840 ventilator experienced a graphical user interface (gui) key stuck alert while being used on a patient.The pt was removed and placed on an alternate ventilator.No pt injuries were reported as a result of the event.

Manufacturer Narrative

A covidien technical support engineer (tse) assisted the customer with troubleshooting the ventilator via phone.The tse suggested that the customer replace the ventilator keyboard.The parts to repair the device were ordered but have not been received by the customer.This report is currently being investigated.As add'l info is received, a supplemental report will be issued.(b)(4).

• Brand Name: 840 VENTILATOR
• Manufacturer (Section D): COVIDIEN; mervue; galway ; EI
• Manufacturer (Section G): COVIDIEN; mervue; galway ; EI
• Manufacturer Contact: denise braxton ; 6135 gunbarrel ave; boulder, CO ; 3038768909
• MDR Report Key: 3701003
• MDR Text Key: 4336353
• Report Number: 8020893-2014-00589
• 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: Biomedical Engineer
• 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?: No
• Date Device Manufactured: 08/01/2002
• 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