MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 980

Device Problems Device Alarm System (1012); Defective Alarm (1014)

Patient Problem No Patient Involvement (2645)

Event Date 07/12/2018

Event Type  malfunction  

Manufacturer Narrative

Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that a 980 ventilator graphical user interface (gui) audio failed.The ventilator was not in use on a patient at the time of the reported event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation summary: the service engineer (se) inspected the device and found the graphical user interface (gui) audio buzzer not working.The se determined the part needs to be replaced.Further service actions and outcomes have not been detailed at this time.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction to evaluation codes result.Device evaluation summary: the service engineer (se) inspected the device and replaced the speaker, exhalation valve and the graphical user interface printed circuit board assembly (pcba).The ventilator passed all testing per manufacturing specification and was placed back into clinical use.If the replaced parts are returned for failure investigation, a supplemental medwatch report with the findings will be submitted once the investigation is complete.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 980 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; michael collins road mervue; galway
• Manufacturer (Section G): COVIDIEN; michael collins road mervue; galway
• Manufacturer Contact: kelly adams ; 2101 faraday ave.; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 7700087
• MDR Text Key: 114698104
• Report Number: 8020893-2018-00319
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521201897
• UDI-Public: 10884521201897
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K162738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• 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: 980A1ENNISB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2015
• 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