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 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

Covidien reference: (b)(4).

Event Description

It was reported that, during maintenance, the ventilator's lower display became dim.There was no patient involvement.

Manufacturer Narrative

(b)(4).The device was evaluated and the liquid crystal display (lcd) panel was replaced.

Manufacturer Narrative

The suspect component was returned to covidien/ medtronic¿s product analysis. a visual inspection of the returned component was performed.The returned component was installed into a test ventilator for analysis.An investigation was performed and the product analysis technician reported that the reported issue was verified.The identified root cause of the reported issue was an incorrect installation.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 hamsphire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5465005
• MDR Text Key: 39448584
• Report Number: 8020893-2016-00450
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K970460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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: 840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2016
• Initial Date FDA Received: 02/26/2016
• Supplement Dates Manufacturer Received: Not provided; 03/03/2016
• Supplement Dates FDA Received: 04/08/2016; 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2015
• 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