MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; CONTINUOUS VENTILATOR

Model Number 840

Device Problem Poor Quality Image (1408)

Patient Problem No Patient Involvement (2645)

Event Date 03/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The covidien technical support engineer (tse) troubleshot this issue with the customer over the phone.Tse recommended replacement of the graphic user interface (gui) central processing unit (cpu) printed circuit board (pcb) and backlight inverter printed circuit board (pcbs).The customer requested a written quote for the repair service.Covidien has not been authorized to repair the device.

Event Description

Covidien received information stating that the top display on an 840 ventilator is fragmented.The ventilator was not in use on a patient at the time the malfunction occurred.

Manufacturer Narrative

(b)(4).The service engineer (se) verified the event and replaced the graphical user interface (gui) printed circuit board (pcb).The unit passed all testing and operates within the manufacturing specifications.

Manufacturer Narrative

The device was repaired and the reported issue was isolated to interface between the device and the failed component.If information is provided in the future, a supplemental report will be issued.

• 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: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5573806
• MDR Text Key: 43037505
• Report Number: 8020893-2016-00874
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2017

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 Number: 840
• Device Catalogue Number: 4-840120DIUU-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 04/13/2016
• Supplement Dates Manufacturer Received: Not provided; 06/29/2016
• Supplement Dates FDA Received: 07/05/2016; 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2001
• 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