MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; CONTINUOUS VENTILATOR

Model Number 840

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service engineer (fse) evaluated the ventilator and verified the reported issue.The fse replaced the keyboard printed circuit board (pcb), which resolved the reported issue.The ventilator then passed all testing.

Event Description

It was reported that a ventilator keyboard was stuck.The ventilator was not on a patient at the time of the event.

• 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: 5092261
• MDR Text Key: 26508774
• Report Number: 8020893-2015-00941
• 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
• Report Date: 08/26/2015

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: 840
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2014
• 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