MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; CONTINUOUS VENTILATOR

Model Number 980

Device Problems Occlusion Within Device (1423); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The service engineer (se) inspected the device and was not able to duplicate the reported issue.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, a 980 ventilator generated an occlusion alarm.The patient was removed from the ventilator and placed on an alternate ventilator.The patient was not harmed or injured as a result of the reported event.

• 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: 6329691
• MDR Text Key: 67386237
• Report Number: 8020893-2017-00532
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2017

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: 01/18/2017
• Initial Date FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2016
• 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