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

Model Number 980

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

Covidien /medtronic has not received the device component from the customer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that, while in use on a patient, a 980 ventilator display turned off, alarmed constantly and stopped cycling while in pressure support mode.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.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluation summary: the field service engineer (fse) evaluated the device and replaced the graphical user interface (gui), breath delivery (bd) central processing unit (cpu) and oxygen sensor.The ventilator passed all testing per manufacturing specification and was placed back into clinical use.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; micheal collins rd mervue; galway
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway
• Manufacturer Contact: kelly adams ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 7571772
• MDR Text Key: 110170399
• Report Number: 8020893-2018-00250
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521171633
• UDI-Public: 10884521171633
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• 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: 980X1ESDIEC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2015
• 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 Age: 67 YR
• Patient Weight: 60