MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; CONTINUOUS VENTILATOR

Model Number 980

Device Problems Device Emits Odor (1425); Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2016

Event Type  malfunction  

Manufacturer Narrative

Covidien reference number (b)(4).At this time, no conclusion can be drawn.The evaluation of the device has not been concluded.

Event Description

It was reported that, when powered on a 980 ventilator did not start up and had a burnt smell.The ventilator was not in use on a patient at the time the event occurred.

Manufacturer Narrative

(b)(4).The covidien service engineer (se) inspected the device and verified the reported issue.The se replaced the graphic user interface (gui) printed circuit board (pcb), breath delivery (bd) power distribution pcb and the bd power controller pcb.The se performed extended self-testing on the device and all tests passed.

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 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: 980 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: 5878480
• MDR Text Key: 52191869
• Report Number: 8020893-2016-02069
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131252
• 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

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 980
• Device Catalogue Number: 980
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2015
• 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