MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; CONTINUOUS VENTILATOR

Model Number 980

Device Problem Poor Quality Image (1408)

Patient Problem No Information (3190)

Event Date 09/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The service engineer (se) inspected the device and replaced the graphic user interface (gui) light emitting diode (led) and the gui central processing unit (cpu) printed circuit board (pcb).The se performed extended self-testing on the device and all tests passed.

Event Description

It was reported that, while in use on a patient, the display on a 980 ventilator had a line across the screen.The patient was removed from the ventilator and placed on an alternate ventilator.Although requested, patient outcome was not provided.

• 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: 6031999
• MDR Text Key: 57551667
• Report Number: 8020893-2016-02677
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2015
• 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
• Patient Outcome(s): Required Intervention