MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; CONTINUOUS VENTILATOR

Model Number 840

Device Problems Device Emits Odor (1425); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The service engineer (se) verified the malfunction and replaced the analog interface (ai) printed circuit board (pcb).The unit passed all testing and operates within the manufacturing specifications.

Event Description

It was reported that an 840 ventilator had an alert message; breath delivery (bd) power on self-test (post) failure with burnt smell.The ventilator was not in use on a patient at the time the malfunction occurred.

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: ray maroofian ; 2101 faraday ave.; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 5942907
• MDR Text Key: 54764425
• Report Number: 8020893-2016-02354
• 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
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• 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: 10049998
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2011
• 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